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BIOMET 3I, LLC

Last updated May 24, 2026

What BIOMET 3I, LLC makes

BIOMET 3I, LLC manufactures dental implants and related products, including screw endosteal implants, both permanent and temporary suprastructure components, dental drill bits (reusable and single-use), surgical screwdrivers, and bone taps.

The company's products are regulated as Class I and Class II medical devices and are listed in the FDA UDI registry. BIOMET 3I, LLC is based in the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What does BIOMET 3I, LLC manufacture?

BIOMET 3I, LLC manufactures dental implants and related products, including screw endosteal dental implants, both permanent and temporary dental implant suprastructure components, dental drill bits (reusable and single-use), surgical screwdrivers, bone taps, and dental regeneration membranes.

Where is BIOMET 3I, LLC based?

BIOMET 3I, LLC is based in the United States, as indicated by the country information provided in the device data.

Which regulatory registries list BIOMET 3I, LLC's devices?

BIOMET 3I, LLC's devices are listed in the FDA UDI registry, which is the only registry mentioned in the provided device data for this company.

How are BIOMET 3I, LLC's devices classified?

BIOMET 3I, LLC's devices are regulated as Class I and Class II medical devices, with Class II being the most common classification for their dental implant products and related components.

AI-generated from registry data and not verified by a human reviewer.

Information

Country: US
Address: —
Website: biomet.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +1(800)342-5454
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: —
DUNS Number: 186127825

Catalogue (2523)

Page 47 of 51

Device	Model / Reference	Registries	Class	Status
Certain® Provide®	PAK5140	FDA UDI	Class II	Unknown
Certain® Prevail®	IIOS5613	FDA UDI	Class II	Unknown
Navigator®	SGSD34	FDA UDI	Class I	Active
Certain®	IMMCS1	FDA UDI	Class II	Active
Certain® Twist Lock™	IIIC45	FDA UDI	Class I	Active
Ep® Twist Lock™	CIC56	FDA UDI	Class I	Active
Certain® Bellatek® Encode®	IEEHA6685	FDA UDI	Class II	Active
3i T3®	BOSS411	FDA UDI	Class II	Active
Certain® Preformance®	IPFTC41	FDA UDI	Class II	Active
Certain® Ginighue®	IMAP352G	FDA UDI	Class II	Active
Navigator®	SGD425Z	FDA UDI	Class I	Active
Osseotite Xp® Certain®	IOS4585	FDA UDI	Class II	Unknown
Dríva™ Gold Series Drills	TSV38G	FDA UDI	Class I	Active
Nanotite™certain®prevail®	NIITP4385	FDA UDI	Class II	Active
Act®	ACT2715SP	EUDAMEDFDA UDI	Class I	Active
3i T3®	BOES3785	FDA UDI	Class II	Active
3i T3® DCD®	BNSS510	FDA UDI	Class II	Active
Locator®	LOA8397	FDA UDI	Class I	Active
Osseoguard®	TR250PW-2	FDA UDI	Class II	Active
Certain® Twist Lock™	IWIT67	FDA UDI	Class I	Active
3i T3®	BOPT5413	FDA UDI	Class II	Active
3i T3® DCD®	BNPT5485	FDA UDI	Class II	Active
Locator®	LORHK	FDA UDI	Class II	Active
Ep®	WIP66	FDA UDI	Class I	Active
Navigator®	SGD385Z	FDA UDI	Class I	Active
Certain® Ep®	IWTH64	FDA UDI	Class II	Active
Navigator®	SGD385Y	FDA UDI	Class I	Active
Locator®	LELARM	FDA UDI	Class II	Active
3i T3® SHORT DCD®	BNES605	FDA UDI	Class II	Active
Nanotite™certain®prevail®	NIIOS4511	FDA UDI	Class II	Unknown
Nanotite™certain®prevail®	NIIOS5411	FDA UDI	Class II	Unknown
Navigator®	SGTD413L	FDA UDI	Class I	Active
3i T3®	BOET3213	FDA UDI	Class II	Active
Navigator®	MSGSD	EUDAMEDFDA UDI	Class I	Active
3i T3® DCD®	BNST485	FDA UDI	Class II	Active
Navigator®	SGTT415S	FDA UDI	Class I	Active
Certain Zireal Gold-Tite	IZSHG	FDA UDI	Class II	Active
Navigator® Certain®	SGIIM52	EUDAMEDFDA UDI	Class I	Active
Certain®, Gold-Tite®	IWPC62C	FDA UDI	Class II	Unknown
Osseoguard®	NTXR2530-4	FDA UDI	Class II	Active
Osseoguard®	TR150TCS-1	FDA UDI	Class II	Active
3i T3®	BOST511	FDA UDI	Class II	Active
Locator®	LOA003	FDA UDI	Class II	Active
Latch-Lock Hex Driver Tip with GemLock Retention 1.2mm (D) X 24mm (L)	IHX1.2D	FDA UDI	Class I	Active
Navigator® Certain®	SGTILKIT	FDA UDI	Class I	Active
Certain® Preformance®	IPFP456	FDA UDI	Class II	Active
Certain® Twist Lock™	IWIT55	FDA UDI	Class I	Active
Osseoguard®	TR150TCL-1	FDA UDI	Class II	Active
Ep®	WIP67	FDA UDI	Class I	Active
Osseoguard®	TR250SMT-2	FDA UDI	Class II	Active

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Recalls (100)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Biomet 3i, LLC has 240 recall records initiated between 2006-12-11 and 2020-08-31, all with a status of terminated. The reasons for recall include mislabeling of packages, potential sterility issues, inadequate biocompatibility testing, seating problems, incorrect manufacturing of internal threads and hex features, drill malfunctions, reports of abutment fractures, and oversized copings.

AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.

Date	Recall No.	Class	Status	Reason
Aug 31, 2020	Z-0077-2021	—	terminated	Hex of the BellaTek Encode Definitive Abutments was misaligned by 30 degrees during manufacturing as compared with the provided patient scan data (Images may cause misalignment, the definitive abutment will not seat in the correct orientation upon attempted placement with the patient
Aug 31, 2020	Z-0076-2021	—	terminated	Hex of the BellaTek Encode Definitive Abutments was misaligned by 30 degrees during manufacturing as compared with the provided patient scan data (Images may cause misalignment, the definitive abutment will not seat in the correct orientation upon attempted placement with the patient
Aug 31, 2020	Z-0078-2021	—	terminated	Hex of the BellaTek Encode Definitive Abutments was misaligned by 30 degrees during manufacturing as compared with the provided patient scan data (Images may cause misalignment, the definitive abutment will not seat in the correct orientation upon attempted placement with the patient
Aug 31, 2020	Z-0075-2021	—	terminated	Hex of the BellaTek Encode Definitive Abutments was misaligned by 30 degrees during manufacturing as compared with the provided patient scan data (Images may cause misalignment, the definitive abutment will not seat in the correct orientation upon attempted placement with the patient
Aug 31, 2020	Z-0074-2021	—	terminated	Hex of the BellaTek Encode Definitive Abutments was misaligned by 30 degrees during manufacturing as compared with the provided patient scan data (Images may cause misalignment, the definitive abutment will not seat in the correct orientation upon attempted placement with the patient
Aug 31, 2020	Z-0073-2021	—	terminated	Hex of the BellaTek Encode Definitive Abutments was misaligned by 30 degrees during manufacturing as compared with the provided patient scan data (Images may cause misalignment, the definitive abutment will not seat in the correct orientation upon attempted placement with the patient
Aug 31, 2020	Z-0079-2021	—	terminated	Hex of the BellaTek Encode Definitive Abutments was misaligned by 30 degrees during manufacturing as compared with the provided patient scan data (Images may cause misalignment, the definitive abutment will not seat in the correct orientation upon attempted placement with the patient
Jan 10, 2020	Z-1380-2020	—	terminated	Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment
Jan 10, 2020	Z-1375-2020	—	terminated	Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment
Jan 10, 2020	Z-1383-2020	—	terminated	Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment
Jan 10, 2020	Z-1370-2020	—	terminated	Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment
Jan 10, 2020	Z-1374-2020	—	terminated	Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment
Jan 10, 2020	Z-1371-2020	—	terminated	Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment
Jan 10, 2020	Z-1366-2020	—	terminated	Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment
Jan 10, 2020	Z-1369-2020	—	terminated	Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment
Jan 10, 2020	Z-1372-2020	—	terminated	Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment
Jan 10, 2020	Z-1381-2020	—	terminated	Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment
Jan 10, 2020	Z-1386-2020	—	terminated	Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment
Jan 10, 2020	Z-1382-2020	—	terminated	Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment
Jan 10, 2020	Z-1376-2020	—	terminated	Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment
Jan 10, 2020	Z-1368-2020	—	terminated	Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment
Jan 10, 2020	Z-1387-2020	—	terminated	Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment
Jan 10, 2020	Z-1367-2020	—	terminated	Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment
Jan 10, 2020	Z-1379-2020	—	terminated	Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment
Jan 10, 2020	Z-1388-2020	—	terminated	Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment
Jan 10, 2020	Z-1377-2020	—	terminated	Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment
Jan 10, 2020	Z-1384-2020	—	terminated	Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment
Jan 10, 2020	Z-1385-2020	—	terminated	Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment
Jan 10, 2020	Z-1378-2020	—	terminated	Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment
Jan 10, 2020	Z-1373-2020	—	terminated	Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment
Feb 26, 2019	Z-2143-2019	—	terminated	During manufacturing, the screw stop ledge was not made to specification and location within the abutment, resulting in the screw head seating deeper in the abutment with no positive stop.
Feb 26, 2019	Z-2142-2019	—	terminated	During manufacturing, the screw stop ledge was not made to specification and location within the abutment, resulting in the screw head seating deeper in the abutment with no positive stop.
Feb 26, 2019	Z-2141-2019	—	terminated	During manufacturing, the screw stop ledge was not made to specification and location within the abutment, resulting in the screw head seating deeper in the abutment with no positive stop.
Feb 26, 2019	Z-2144-2019	—	terminated	During manufacturing, the screw stop ledge was not made to specification and location within the abutment, resulting in the screw head seating deeper in the abutment with no positive stop.
Feb 26, 2019	Z-2140-2019	—	terminated	During manufacturing, the screw stop ledge was not made to specification and location within the abutment, resulting in the screw head seating deeper in the abutment with no positive stop.
Mar 8, 2017	Z-1701-2017	—	terminated	A single lot of product that potentially has a single part within the lot that does not match the product on the label due to a commingle at the firm supplier
Sep 14, 2016	Z-0835-2017	—	terminated	A limited number of product pouches may not have been sealed during packaging.
Sep 14, 2016	Z-0831-2017	—	terminated	A limited number of product pouches may not have been sealed during packaging.
Sep 14, 2016	Z-0860-2017	—	terminated	A limited number of product pouches may not have been sealed during packaging.
Sep 14, 2016	Z-0849-2017	—	terminated	A limited number of product pouches may not have been sealed during packaging.
Sep 14, 2016	Z-0841-2017	—	terminated	A limited number of product pouches may not have been sealed during packaging.
Sep 14, 2016	Z-0836-2017	—	terminated	A limited number of product pouches may not have been sealed during packaging.
Sep 14, 2016	Z-0846-2017	—	terminated	A limited number of product pouches may not have been sealed during packaging.
Sep 14, 2016	Z-0861-2017	—	terminated	A limited number of product pouches may not have been sealed during packaging.
Sep 14, 2016	Z-0848-2017	—	terminated	A limited number of product pouches may not have been sealed during packaging.
Sep 14, 2016	Z-0854-2017	—	terminated	A limited number of product pouches may not have been sealed during packaging.
Sep 14, 2016	Z-0857-2017	—	terminated	A limited number of product pouches may not have been sealed during packaging.
Sep 14, 2016	Z-0862-2017	—	terminated	A limited number of product pouches may not have been sealed during packaging.
Sep 14, 2016	Z-0847-2017	—	terminated	A limited number of product pouches may not have been sealed during packaging.
Sep 14, 2016	Z-0838-2017	—	terminated	A limited number of product pouches may not have been sealed during packaging.
Sep 14, 2016	Z-0842-2017	—	terminated	A limited number of product pouches may not have been sealed during packaging.
Sep 14, 2016	Z-0830-2017	—	terminated	A limited number of product pouches may not have been sealed during packaging.
Sep 14, 2016	Z-0844-2017	—	terminated	A limited number of product pouches may not have been sealed during packaging.
Sep 14, 2016	Z-0845-2017	—	terminated	A limited number of product pouches may not have been sealed during packaging.
Sep 14, 2016	Z-0856-2017	—	terminated	A limited number of product pouches may not have been sealed during packaging.
Sep 14, 2016	Z-0855-2017	—	terminated	A limited number of product pouches may not have been sealed during packaging.
Sep 14, 2016	Z-0851-2017	—	terminated	A limited number of product pouches may not have been sealed during packaging.
Sep 14, 2016	Z-0852-2017	—	terminated	A limited number of product pouches may not have been sealed during packaging.
Sep 14, 2016	Z-0850-2017	—	terminated	A limited number of product pouches may not have been sealed during packaging.
Sep 14, 2016	Z-0829-2017	—	terminated	A limited number of product pouches may not have been sealed during packaging.
Sep 14, 2016	Z-0853-2017	—	terminated	A limited number of product pouches may not have been sealed during packaging.
Sep 14, 2016	Z-0834-2017	—	terminated	A limited number of product pouches may not have been sealed during packaging.
Sep 14, 2016	Z-0859-2017	—	terminated	A limited number of product pouches may not have been sealed during packaging.
Sep 14, 2016	Z-0833-2017	—	terminated	A limited number of product pouches may not have been sealed during packaging.
Sep 14, 2016	Z-0840-2017	—	terminated	A limited number of product pouches may not have been sealed during packaging.
Sep 14, 2016	Z-0828-2017	—	terminated	A limited number of product pouches may not have been sealed during packaging.
Sep 14, 2016	Z-0843-2017	—	terminated	A limited number of product pouches may not have been sealed during packaging.
Sep 14, 2016	Z-0837-2017	—	terminated	A limited number of product pouches may not have been sealed during packaging.
Sep 14, 2016	Z-0863-2017	—	terminated	A limited number of product pouches may not have been sealed during packaging.
Sep 14, 2016	Z-0839-2017	—	terminated	A limited number of product pouches may not have been sealed during packaging.
Sep 14, 2016	Z-0832-2017	—	terminated	A limited number of product pouches may not have been sealed during packaging.
Sep 14, 2016	Z-0858-2017	—	terminated	A limited number of product pouches may not have been sealed during packaging.
Aug 8, 2016	Z-2845-2016	—	terminated	Product was incorrectly packaged.
Nov 25, 2015	Z-2481-2016	—	terminated	Pouches may not have been sealed during packing.
Nov 25, 2015	Z-2410-2016	—	terminated	Pouches may not have been sealed during packing.
Nov 25, 2015	Z-2466-2016	—	terminated	Pouches may not have been sealed during packing.
Nov 25, 2015	Z-2454-2016	—	terminated	Pouches may not have been sealed during packing.
Nov 25, 2015	Z-2522-2016	—	terminated	Pouches may not have been sealed during packing.
Nov 25, 2015	Z-2471-2016	—	terminated	Pouches may not have been sealed during packing.
Nov 25, 2015	Z-2461-2016	—	terminated	Pouches may not have been sealed during packing.
Nov 25, 2015	Z-2415-2016	—	terminated	Pouches may not have been sealed during packing.
Nov 25, 2015	Z-2487-2016	—	terminated	Pouches may not have been sealed during packing.
Nov 25, 2015	Z-2449-2016	—	terminated	Pouches may not have been sealed during packing.
Nov 25, 2015	Z-2465-2016	—	terminated	Pouches may not have been sealed during packing.
Nov 25, 2015	Z-2445-2016	—	terminated	Pouches may not have been sealed during packing.
Nov 25, 2015	Z-2420-2016	—	terminated	Pouches may not have been sealed during packing.
Nov 25, 2015	Z-2470-2016	—	terminated	Pouches may not have been sealed during packing.
Nov 25, 2015	Z-2456-2016	—	terminated	Pouches may not have been sealed during packing.
Nov 25, 2015	Z-2463-2016	—	terminated	Pouches may not have been sealed during packing.
Nov 25, 2015	Z-2479-2016	—	terminated	Pouches may not have been sealed during packing.
Nov 25, 2015	Z-2477-2016	—	terminated	Pouches may not have been sealed during packing.
Nov 25, 2015	Z-2423-2016	—	terminated	Pouches may not have been sealed during packing.
Nov 25, 2015	Z-2427-2016	—	terminated	Pouches may not have been sealed during packing.
Nov 25, 2015	Z-2434-2016	—	terminated	Pouches may not have been sealed during packing.
Nov 25, 2015	Z-2516-2016	—	terminated	Pouches may not have been sealed during packing.
Nov 25, 2015	Z-2519-2016	—	terminated	Pouches may not have been sealed during packing.
Nov 25, 2015	Z-2441-2016	—	terminated	Pouches may not have been sealed during packing.
Nov 25, 2015	Z-2417-2016	—	terminated	Pouches may not have been sealed during packing.
Nov 25, 2015	Z-2408-2016	—	terminated	Pouches may not have been sealed during packing.
Nov 25, 2015	Z-2426-2016	—	terminated	Pouches may not have been sealed during packing.