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ZIMMER DENTAL INC.

Last updated May 24, 2026

What ZIMMER DENTAL INC. makes

Zimmer Dental Inc. makes dental implant suprastructures, including permanent and temporary preformed components, as well as two-piece screw endosteal dental implants. The company also produces reusable and single-use dental drill bits, drill bit extensions, reusable surgical drill guides, and reusable steel dental burs.

The devices in Zimmer Dental Inc.'s portfolio are classified as Class I and Class II medical devices and are listed in the FDA's Unique Device Identification (fda_udi) system. The company 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 Zimmer Dental Inc. make?

Where is Zimmer Dental Inc. based?

Zimmer Dental Inc. is based in the United States, as stated in the provided data under the COUNTRY field.

Which registries list Zimmer Dental Inc.'s devices?

Zimmer Dental Inc.'s devices are listed in the FDA's Unique Device Identification (fda_udi) system, as indicated in the LISTED IN field of the device data.

How are Zimmer Dental Inc.'s devices classified?

Zimmer Dental Inc.'s devices are classified as Class I and Class II medical devices, according to the DEVICE CLASSES field in the provided data.

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

Information

Country: US
Address: —
Website: zimmer.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +1(800)854-7019
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: —
DUNS Number: 103167086

Catalogue (1089)

Page 22 of 22

Device	Model / Reference	Registries	Class	Status
Tapered Screw-Vent Implant, 4.1mm, Models: Tsv4b8, B10, B11, B13 And B16, Tsv4h8, H11, H13 And H16	K072589	FDA 510(k)	Class II	Active
Zimmer Dental Tapered Swissplus Implants	K082639	FDA 510(k)	Class II	Active
Zimmer Patient-Specific Ceramic Abutment	K080164	FDA 510(k)	Class II	Active
Zimmer Zfx Titanium Abutment For Straumann Bone Level Implant System	K141120	FDA 510(k)	Class II	Active
Zimmer Dental Tapered Screw-Vent X	K113753	FDA 510(k)	Class II	Active
Screw-Vent Implant System, Sv;tapered Screw -vent Implant System, Tsv;advent Implant System, Av;zimmer One-Piece Implant	K061410	FDA 510(k)	Class II	Active
Zimmer Zfx Abutment For Nobel Replace Implant System	K120873	FDA 510(k)	Class II	Active
Zimmer Angled Contour Zirconia Abutment	K083474	FDA 510(k)	Class II	Active
Zimmer Contour Restorative System	K061043	FDA 510(k)	Class II	Active
3.25 Spline Twist Implant, Ha Coated	K093164	FDA 510(k)	Class II	Active
Hex-Lock Short Abutment, Model Sa341, Sa342, Sa451, Sa452, Sa561, Sa562 Short Healing Cap, Model Saheal4, Saheal5,	K090723	FDA 510(k)	Class II	Active
Zimmer Contour Ceramic Abutment, Models Zra341s, Zra342s, Kra451s, Zra452s	K061847	FDA 510(k)	Class II	Active
Tapered Screw-Vent T Implant	K101977	FDA 510(k)	Class II	Active
Anodized Healing Collar	K111852	FDA 510(k)	Class II	Active
Zimmer Contour Provisional Coping	K113092	FDA 510(k)	Class II	Active
Tapered Screw-Vent X Implant	K112160	FDA 510(k)	Class II	Active
Zimmer One-Piece Implant, 3.7 Mm, Angled	K061717	FDA 510(k)	Class II	Active
Zimmer One Piece Implant, 3.7mm And 4.7mm, Models Zop37s10, 11, 13, 16; Zop37a10, 11, 13, 16; Zop47s10, 11, 13, 16; Zop4	K063523	FDA 510(k)	Class II	Active
Zimmer Dental Tapered Screw Vent T Implant, Ha Coated;zimmer Dental Tapered Screw-Vent M Implant, Ha Coated	K133339	FDA 510(k)	Class II	Active
Zimmer Cast-to Gold Abutments for the 3.1mmD Dental Implant System	K143528	FDA 510(k)	Class II	Active
Zimmer Zfx Abutment for Zimmer 3.1mmD Implant System	K142572	FDA 510(k)	Class II	Active
Ti Prepable Abutment, Model 1618, 1619, 1620	K092403	FDA 510(k)	Class II	Active
Zimmer Zfx Titanium Base Abutment For Tapered Screwvent Implant System	K133551	FDA 510(k)	Class II	Active
Zimmer 3.1mm Dental Implant;2.9mm Angled Abutment;straight Hex, 2.9mm Contour Abutement	K142082	FDA 510(k)	Class II	Active
Plastic Temporary Abutments, Models: Pt341s, Pt344s, Pt341a, Pt344a, Pt451s, Pt454s, Pt451a, Pt454a, Pt561s, Pt564s	K092377	FDA 510(k)	Class II	Active
Tapered Screw-Vent T Implant, Tapered Screw-Vent P Implant	K101880	FDA 510(k)	Class II	Active
Zimmer Patient-Specific Abutment, Internal Hex, Titanium	K143505	FDA 510(k)	Class II	Active
MRI Compatibility for Existing Zimmer Dental Implant Systems	K160398	FDA 510(k)	Class II	Active
Zimmer One Piece Implant, 3.0mm Angled, Models Zop30a10, Zop30a11 And Zop30a13	K071235	FDA 510(k)	Class II	Active
Zimmer Dental Trabecular Metal Implant System	K132258	FDA 510(k)	Class II	Active
Zimmer One-Piece Implant, 4.7mm, Straight, Models Zop47s10, Zop47s11, Zop47s13, Zop47s16	K062281	FDA 510(k)	Class II	Active
Angled Tapered Abutment	K111853	FDA 510(k)	Class II	Active
Zimmer Zfx Titanium Abutment For Biomet 3i Certain Implant System	K141544	FDA 510(k)	Class II	Active
Zimmer Patient-Specific Abutment, Internal Hex, Titanium	K071439	FDA 510(k)	Class II	Active
Zimmer Dental Tapered Screw-Vent M Implant	K111889	FDA 510(k)	Class II	Active
Zfx Dental Cad System	K121709	FDA 510(k)	Class II	Active
Zimmer Dental Hex-Lock Prepared Abutment (straight & Angled)	K052600	FDA 510(k)	Class II	Active
Zimmer Dental One Piece Tapered Abutment, Models Tac1, Tacw1, Ta5c1	K060880	FDA 510(k)	Class II	Active
Zimmer Zfx Titanium Abutment, Base Abutment And Abutment Blank For Nobelactive Implant System	K134045	FDA 510(k)	Class II	Active

Related Companies

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FDA Recalls (40)

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

Zimmer Dental Inc. has 40 recall records initiated between 2004-01-13 and 2018-05-10, all with a status of terminated. The reasons for recall include sterility barrier compromised, incorrect diameter size printed on inner vial, manufacturing conditions affecting driver's hex feature, internal thread diameter below specification, cracked implant vial caps, omitted information in IFUs, incorrect labeling on Cap Label, commingled lots during manufacturing, incorrect item/lot numbers on inner package labeling, Gemlock Long Hex Driver fitting issues, and missing supplemental IFUs.

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
May 10, 2018	Z-2963-2018	—	terminated	Dental implants have incorrect item/lot numbers and size on the inner package labeling. Correct item/lot numbers and size are on the outer package labeling.
Nov 29, 2017	Z-1189-2018	—	terminated	Two lots of the Tapered Screw-Vent Implants, with different outer thread diameters, were inadvertently commingled during the manufacturing process and may be mislabeled.
Nov 29, 2017	Z-1190-2018	—	terminated	Two lots of the Tapered Screw-Vent Implants, with different outer thread diameters, were inadvertently commingled during the manufacturing process and may be mislabeled.
Nov 20, 2017	Z-0284-2018	—	terminated	Some implant vial caps in the recalled implant lot may inadvertently crack as the result of a manufacturing assembly condition.
Oct 11, 2017	Z-0280-2018	—	terminated	The device may contain a manufacturing condition affecting the geometry of the driver's hex feature which prevents it from properly engaging the fixture mount transfer and/or a dental implant.
Oct 11, 2017	Z-0282-2018	—	terminated	The device may contain a manufacturing condition affecting the geometry of the driver's hex feature which prevents it from properly engaging the fixture mount transfer and/or a dental implant.
Oct 11, 2017	Z-0281-2018	—	terminated	The device may contain a manufacturing condition affecting the geometry of the driver's hex feature which prevents it from properly engaging the fixture mount transfer and/or a dental implant.
Oct 11, 2017	Z-0279-2018	—	terminated	The device may contain a manufacturing condition affecting the geometry of the driver's hex feature which prevents it from properly engaging the fixture mount transfer and/or a dental implant.
Jul 10, 2017	Z-3210-2017	—	terminated	Zimmer Biomet is conducting a medical device field correction for various dental products due to several parts being shipped to the customer with only standard IFUs. All the products were missing supplemental IFUs.
Jul 10, 2017	Z-3207-2017	—	terminated	Zimmer Biomet is conducting a medical device field correction for various dental products due to several parts being shipped to the customer with only standard IFUs. All the products were missing supplemental IFUs.
Jul 10, 2017	Z-3204-2017	—	terminated	Zimmer Biomet is conducting a medical device field correction for various dental products due to several parts being shipped to the customer with only standard IFUs. All the products were missing supplemental IFUs.
Jul 10, 2017	Z-3205-2017	—	terminated	Zimmer Biomet is conducting a medical device field correction for various dental products due to several parts being shipped to the customer with only standard IFUs. All the products were missing supplemental IFUs.
Jul 10, 2017	Z-3209-2017	—	terminated	Zimmer Biomet is conducting a medical device field correction for various dental products due to several parts being shipped to the customer with only standard IFUs. All the products were missing supplemental IFUs.
Jul 10, 2017	Z-3208-2017	—	terminated	Zimmer Biomet is conducting a medical device field correction for various dental products due to several parts being shipped to the customer with only standard IFUs. All the products were missing supplemental IFUs.
Jul 10, 2017	Z-3206-2017	—	terminated	Zimmer Biomet is conducting a medical device field correction for various dental products due to several parts being shipped to the customer with only standard IFUs. All the products were missing supplemental IFUs.
Mar 20, 2017	Z-1823-2017	—	terminated	It was manufactured with the minor diameter of the internal thread that is below specification.
Jan 6, 2016	Z-0773-2016	—	terminated	Information specific to the 3.7 mmD and 4.1 mmD Trabecular Metal Zimmer Dental Implants was omitted from the latest revision of the applicable IFU in the Indications, Contraindications, and Precautions sections.
Jan 6, 2016	Z-0776-2016	—	terminated	Information specific to the 3.7 mmD and 4.1 mmD Trabecular Metal Zimmer Dental Implants was omitted from the latest revision of the applicable IFU in the Indications, Contraindications, and Precautions sections.
Jan 6, 2016	Z-0784-2016	—	terminated	Information specific to the 3.7 mmD and 4.1 mmD Trabecular Metal Zimmer Dental Implants was omitted from the latest revision of the applicable IFU in the Indications, Contraindications, and Precautions sections.
Jan 6, 2016	Z-0778-2016	—	terminated	Information specific to the 3.7 mmD and 4.1 mmD Trabecular Metal Zimmer Dental Implants was omitted from the latest revision of the applicable IFU in the Indications, Contraindications, and Precautions sections.
Jan 6, 2016	Z-0775-2016	—	terminated	Information specific to the 3.7 mmD and 4.1 mmD Trabecular Metal Zimmer Dental Implants was omitted from the latest revision of the applicable IFU in the Indications, Contraindications, and Precautions sections.
Jan 6, 2016	Z-0781-2016	—	terminated	Information specific to the 3.7 mmD and 4.1 mmD Trabecular Metal Zimmer Dental Implants was omitted from the latest revision of the applicable IFU in the Indications, Contraindications, and Precautions sections.
Jan 6, 2016	Z-0772-2016	—	terminated	Information specific to the 3.7 mmD and 4.1 mmD Trabecular Metal Zimmer Dental Implants was omitted from the latest revision of the applicable IFU in the Indications, Contraindications, and Precautions sections.
Jan 6, 2016	Z-0782-2016	—	terminated	Information specific to the 3.7 mmD and 4.1 mmD Trabecular Metal Zimmer Dental Implants was omitted from the latest revision of the applicable IFU in the Indications, Contraindications, and Precautions sections.
Jan 6, 2016	Z-0777-2016	—	terminated	Information specific to the 3.7 mmD and 4.1 mmD Trabecular Metal Zimmer Dental Implants was omitted from the latest revision of the applicable IFU in the Indications, Contraindications, and Precautions sections.
Jan 6, 2016	Z-0774-2016	—	terminated	Information specific to the 3.7 mmD and 4.1 mmD Trabecular Metal Zimmer Dental Implants was omitted from the latest revision of the applicable IFU in the Indications, Contraindications, and Precautions sections.
Jan 6, 2016	Z-0780-2016	—	terminated	Information specific to the 3.7 mmD and 4.1 mmD Trabecular Metal Zimmer Dental Implants was omitted from the latest revision of the applicable IFU in the Indications, Contraindications, and Precautions sections.
Jan 6, 2016	Z-0783-2016	—	terminated	Information specific to the 3.7 mmD and 4.1 mmD Trabecular Metal Zimmer Dental Implants was omitted from the latest revision of the applicable IFU in the Indications, Contraindications, and Precautions sections.
Jan 6, 2016	Z-0779-2016	—	terminated	Information specific to the 3.7 mmD and 4.1 mmD Trabecular Metal Zimmer Dental Implants was omitted from the latest revision of the applicable IFU in the Indications, Contraindications, and Precautions sections.
Jan 22, 2015	Z-1115-2015	—	terminated	The Gemlock Long Hex Driver may not fit into the Fixture Mount Transfer (FMT) or the internal hex of the implant.
Oct 1, 2014	Z-0154-2015	—	terminated	Zimmer Dental is recalling Tapered Screw-Vent Implants because the incorrect diameter size was printed on the inner vial.
Oct 1, 2014	Z-0153-2015	—	terminated	Zimmer Dental is recalling Tapered Screw-Vent Implants because the incorrect diameter size was printed on the inner vial.
Jan 6, 2014	Z-0847-2014	—	terminated	Zimmer Dental is conducting a voluntary recall of a single lot of the Tapered Screw-Vent Implant, Catalog TSVWB11, Lot 62470008, because some of the packages of this lot may have the Cap Label state 3.7 x 10mm instead of 4.7 x 11.5mm.
Jan 13, 2004	Z-1144-04	—	terminated	Sterility barrier compromised.
Jan 13, 2004	Z-1143-04	—	terminated	Sterility barrier compromised.
Jan 13, 2004	Z-1142-04	—	terminated	Sterility barrier compromised.
Jan 13, 2004	Z-1141-04	—	terminated	Sterility barrier compromised.
Jan 13, 2004	Z-1139-04	—	terminated	Sterility barrier compromised.
Jan 13, 2004	Z-1140-04	—	terminated	Sterility barrier compromised.
Jan 13, 2004	Z-1145-04	—	terminated	Sterility barrier compromised.