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Sterngold

USA · Attleboro

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Brazil, Taiwan — 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

12510(k) clearances

Class I 0Class II 0Class III 0

plus 0 registration records and 12 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

4registered devices

Class I 2Class II 2

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

0active device licences

TWTaiwanTFDA

1valid device licences

Class III 1

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 States0 registration records, 12 510(k), 0 PMA, 3 excluded

Brazil4 confirmed, 1 excluded

Canada0 confirmed, 1 excluded

Manufacturer names merged into this page: STERNGOLD

Registration details (sample)

Market	Identifier	Name	Class / date
US	K092434	STERNGOLD 2.2MM ANGLES MICRO ERA DENTAL IMPLANT SYSTEM	2009-11-10
US	K041271	STERNGOLD 3.25 ERA DENTAL IMPLANT SYSTEM	2004-10-28
US	K023580	STERNGOLD ACID ETCH DENTAL IMPLANT SYSTEM	2003-01-17
BR	10346410058	BROCAS ODONTOLÓGICAS STERNGOLD	Class I
BR	10346410059	SISTEMA ERA	Class II
BR	10346410060	ABUTMENTS STERNGOLD	Class II

Sterngold

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

Registration details (sample)

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