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SUNSTAR AMERICAS, INC.

USA · Schaumburg

✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Brazil, Canada, Taiwan — 4 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

10listed device types

Class I 10Class II 0Class III 0

plus 13 registration records and 3 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

3registered devices

Class I 3

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

6active device licences

Class II 4Class III 2

9 including historic records

TWTaiwanTFDA

1valid device licences

Class I 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 States13 registration records, 3 510(k), 0 PMA, 4 excluded

Brazil3 confirmed, 0 excluded

Saudi Arabia0 confirmed, 1 excluded

Canada6 confirmed, 0 excluded

Manufacturer names merged into this page: SUNSTAR AMERICAS, INC. · SUNSTAR AMERICAS INC. · SUNSTAR AMERICAS MÉXICO S. DE R.L. DE C.V.

FDA 510(k) clearances by year

12011 · K102053

12013 · K132325

12018 · K181134

FDA listed device types

showing 8 of 10

Toothbrush, Powered 1Wax, Dental, Intraoral 1Mirror, Mouth 1Explorer, Operative 1Pick, Massaging 1Scraper, Tongue 1Toothbrush, Manual 1Floss, Dental 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K181134	GUM HYDRAL Dry Mouth Oral Gel, GUM HYDRAL Dry Mouth Oral Rinse, GUM HYDRAL Dry Mouth Oral Spray	2018-07-13
US	K132325	GUIDOR BIORESORBABLE MATRIX BARRIER	2013-10-29
US	K102053	BUTLER CALCI-FLOR PROPHYLAXIS PASTE	2011-02-03
BR	81072010001	CERA ORTODÔNTICA	Class I
BR	81072010002	Cera Ortodôntica Neutra	Class I
BR	81072010003	GUM 835 Pastilhas de Limpeza	Class I
CA	71201	PROTECT DESENSITIZER VARNISH	Class III
CA	90558	GUIDOR BIORESORBABLE MATRIX BARRIER	Class III
CA	97453	SORE SHIELD	Class II

SUNSTAR AMERICAS, INC.

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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