Home›USA›Sterngold Dental, LLC

Sterngold Dental, LLC

USA · Attleboro

✓ Record-verifiedregistrations found in 6 markets

This company has registrations in United States, Brazil, Canada, Taiwan, South Korea, Israel — 6 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

15listed device types

Class I 5Class II 10Class III 0

plus 65 registration records and 12 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

3registered devices

Class II 3

6 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

8active device licences

Class II 2Class III 6

21 including historic records

TWTaiwanTFDA

3valid device licences

Class I 2Class II 1

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

1registrations

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 States65 registration records, 12 510(k), 0 PMA, 2 excluded

Brazil3 confirmed, 1 excluded

Canada8 confirmed, 0 excluded

Manufacturer names merged into this page: Sterngold Dental LLC · STERNGOLD DENTAL, LLC · STERNGOLD DENTAL LLC

FDA 510(k) clearances by year

12012

22013

32014 · K142407

42015 · K151928

12016 · K153173

12017 · K171728

FDA listed device types

showing 8 of 15

Sealant, Pit And Fissure, And Conditioner 1Cement, Dental 1Resin, Denture, Relining, Repairing, Rebasing 1Alloy, Gold-Based Noble Metal 1Abutment, Implant, Dental, Endosseous 1Material, Tooth Shade, Resin 1Material, Impression 1Crown And Bridge, Temporary, Resin 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K171728	MOR 3.0mm and PUR NP 3.2mm Implant Systems, MOR 2.1x18mm and 2.4x18mm	2017-09-28
US	K153173	MOR Implant System	2016-02-05
US	K151928	PUR Dental Implant System	2015-11-06
BR	10346419007	DELTAFIL	Class II
BR	10346419008	DELTAFIL CONDITIONER	Class II
BR	10346410106	EZ PickUP	Class II
CA	4664	IMPLANT COVER SCREW, HEXED	Class II
CA	4665	IMZ PREPARATION POST	Class II
CA	12420	PROSTHETIC SCREWS	Class III

Sterngold Dental, LLC

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

Similar companies