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S.I.N. Implant System Ltda

Brazil · Sao Paulo

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Brazil, Canada — 3 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

5listed device types

Class I 2Class II 3Class III 0

plus 33 registration records and 27 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

92registered devices

Class I 76Class II 16

135 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

0active device licences

17 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

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 States33 registration records, 27 510(k), 0 PMA, 113 excluded

Brazil92 confirmed, 8 excluded

Saudi Arabia0 confirmed, 3 excluded

Canada0 confirmed, 19 excluded

Manufacturer names merged into this page: S.I.N. Implant System Ltda · AVINENT IMPLANT SYSTEM S.L.U. · S.I.N. IMPLANT SYSTEM LTDA · BIOHORIZONS IMPLANT SYSTEM INC.

FDA 510(k) clearances by year

12007

22008

32009

32010

12011

12012

52013

32014

12020

12021

52025

12026

FDA listed device types

Implant, Endosseous, Root-Form 1Sterilization Wrap Containers, Trays, Cassettes & Other Accessories 1Abutment, Implant, Dental, Endosseous 1Accessories, Implant, Dental, Endosseous 1Retractor, All Types 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K260527	FACE4D Aligner	2026-07-02
US	K251129	S.I.N. Tapered Pro Conical Zygoma Implant System	2025-11-07
US	K252266	S.I.N. Dental Implant System	2025-10-17
BR	80108910050	FAMÍLIA DE TRANSFERENTE TI S.I.N	Class II
BR	80108910120	KCSE 03 - KIT CIRÚRGICO EPIKUT	Class I
BR	80108910077	KLEV 02 - KIT LEVANTAMENTO DE SEIO S.I.N.	Class I

S.I.N. Implant System Ltda

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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