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Biomet 3i, Inc.

USA · Palm Beach Gardens

✓ Record-verifiedregistrations found in 8 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, South Korea, Israel, Russia — 8 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

32510(k) clearances

Class I 0Class II 0Class III 0

plus 0 registration records and 32 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

17registered devices

Class I 14Class II 3

20 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

7active device licences

Class II 2Class III 5

21 including historic records

TWTaiwanTFDA

4valid device licences

Class I 1Class II 2Class III 1

SGSingaporeHSA SMDR

6device registrations

CLASS B 1CLASS C 5

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

12registrations

RURussiaRoszdravnadzor

5active registrations

Class 2a 3Class 2b 2

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, 32 510(k), 0 PMA

Brazil17 confirmed, 0 excluded

Canada7 confirmed, 0 excluded

Manufacturer names merged into this page: BIOMET 3I, LLC · BIOMET 3I, INC · BIOMET 3I, LLC. · BIOMET 3I LLC · BIOMET 3I

Registration details (sample)

Market	Identifier	Name	Class / date
US	K251660	T3 Pro Implants ZimVie Packaging System	2025-06-27
US	K241753	Immediate Molar Implants	2024-10-23
US	K241032	BellaTek Bars	2024-07-15
BR	80044680014	SISTEMA ABUTMENT LOCATOR	Class II
BR	80117581146	Kit cirúrgico para Implante	Class I
BR	80117581147	BSISK - Kit de Instrumentos Cirúrgicos para Implante T3 Curto 3i	Class I
CA	6212	BIOTACK BIOABSORBABLE MEMBRANE FIXATION TACK	Class III
CA	11435	CYLINDER IMPLANTS	Class III
CA	61918	3I CALCIGEN ORAL BONE GRAFT STABILIZER	Class III

Biomet 3i, Inc.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

Registration details (sample)

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