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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 3 of 22

Device	Model / Reference	Registries	Class	Status
Zimmer ZFX Abutment	ZFX01000253	FDA UDI	Class II	Active
Tapered Screw-Vent® Implant System	15AT434	FDA UDI	Class II	Active
Tapered Screw-Vent®	TSV4B16	FDA UDI	Class II	Active
Tapered Screw-Vent® Implant System	PT451A	FDA UDI	Class II	Active
SwissPlus®	OPA/6	FDA UDI	Class II	Active
Advent®	AVGC5	FDA UDI	Class II	Active
Spline®	1664	FDA UDI	Class II	Active
SwissPlus®	OPC	FDA UDI	Class II	Active
Tapered Screw-Vent®	TW1.25L	EUDAMEDFDA UDI	Class I	Active
Eztetic™	CANP41S	FDA UDI	Class II	Active
Tapered Screw-Vent®	TSVM6B8	FDA UDI	Class II	Active
Spline® Twist™ Implant System	1996	FDA UDI	Class II	Active
Tapered Screw-Vent® Implant System	CAB	EUDAMEDFDA UDI	Class II	Active
Zfx™	ABTCOPZR4R	FDA UDI	Class I	Unknown
Tapered Screw-Vent®	HX3.0-S	EUDAMEDFDA UDI	Class I	Active
Hex-Lock®	ZOA443S	FDA UDI	Class II	Active
Tapered Screw-Vent®	ZOCWAX5A	EUDAMEDFDA UDI	Class I	Active
Tapered Screw-Vent®	TSVT4B8	FDA UDI	Class II	Active
Zfx™	CRNBZR5R	FDA UDI	Class I	Unknown
Tapered Screw-Vent®	HLT4/6	FDA UDI	Class I	Active
Spline®	2740	EUDAMEDFDA UDI	Class I	Active
Tapered Screw-Vent® Implant System	ZCRKIT6S	FDA UDI	Class II	Active
Tapered Screw-Vent®	TSVTB8	FDA UDI	Class II	Active
Tapered Screw-Vent®	TCANA6S	EUDAMEDFDA UDI	Class I	Active
Tapered Screw-Vent®	TSVMWH13	FDA UDI	Class II	Active
Tapered Screw-Vent® Implant System	DHTS	EUDAMEDFDA UDI	Class II	Active
Driva™	TSV4DN	FDA UDI	Class I	Active
Hex-Lock®	ZOA341A	FDA UDI	Class II	Active
Omniloc™	0616	FDA UDI	Class II	Active
Zimmer ZFX Component	TELEZR	FDA UDI	Class II	Active
SwissPlus®	FMTM2	FDA UDI	Class II	Active
Driva™	1215A	FDA UDI	Class I	Active
Tapered Screw-Vent®	DHT4/6	FDA UDI	Class I	Active
Tapered Screw-Vent®	TAD28A	EUDAMEDFDA UDI	Class I	Active
Tapered Screw-Vent®	TSVMWH16	FDA UDI	Class II	Active
Spline Implant System	1565	FDA UDI	Class II	Active
Eztetic®	CITNP41	EUDAMEDFDA UDI	Class I	Active
Eztetic™	CHCNP44	FDA UDI	Class II	Active
Tapered Screw-Vent® Implant System	TA5C4	FDA UDI	Class II	Active
SwissPlus®	OPWSCL	FDA UDI	Class II	Active
Hex-Lock®	HLA3/5	FDA UDI	Class II	Active
Advent®	AVWB8	FDA UDI	Class II	Active
Spline®	1818	FDA UDI	Class II	Active
Screw-Vent ®	SVMB16	FDA UDI	Class II	Active
Tapered Screw-Vent® Implant System	SAHEAL4	FDA UDI	Class II	Active
Omniloc™	0699	EUDAMEDFDA UDI	Class I	Active
SwissPlus®	OPH20	FDA UDI	Class II	Active
Hex-Lock®	ZOA562S	FDA UDI	Class II	Active
Spline®	1649	FDA UDI	Class I	Active
Driva™	SV3.8DN	EUDAMEDFDA UDI	Class I	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 (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.