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Zimmer Dental, Inc.

USA · Carlsbad

✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Israel — 5 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

40510(k) clearances

Class I 0Class II 0Class III 0

plus 0 registration records and 40 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

5registered devices

Class I 4Class II 1

7 including historic records

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

5active device licences

Class III 5

TWTaiwanTFDA

7valid device licences

Class I 1Class II 2Class III 4

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

6registrations

RURussiaRoszdravnadzor

pendingnot queried

Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States0 registration records, 40 510(k), 0 PMA, 51 excluded

Brazil5 confirmed, 22 excluded

Saudi Arabia0 confirmed, 11 excluded

Canada5 confirmed, 15 excluded

Manufacturer names merged into this page: ZIMMER DENTAL INC.

Registration details (sample)

Market	Identifier	Name	Class / date
US	K160398	MRI Compatibility for Existing Zimmer Dental Implant Systems	2017-05-17
US	K143505	Zimmer Patient-Specific Abutment, Internal Hex, Titanium	2015-06-25
US	K143528	Zimmer Cast-to Gold Abutments for the 3.1mmD Dental Implant System	2015-05-01
BR	80117581160	Instrumentos Zimmer Dental NANC	Class I
BR	80117581166	Kit Drill Stop DSKIT	Class I
BR	80117581167	Instrumentos Zimmer Dental de Aprimoramento	Class I
CA	10906	INTEGRAL DENTAL IMPLANT SYSTEM	Class III
CA	12433	CALCITITE HA PARTICLES	Class III
CA	12435	OMNILOC DENTAL IMPLANT SYSTEM	Class III

Zimmer Dental, Inc.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

Registration details (sample)

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