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PRODUITS DENTAIRES SA

Switzerland · Vevey (Suisse) Vaud

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Brazil, Saudi Arabia — 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

17listed device types

Class I 16Class II 1Class III 0

plus 18 registration records and 3 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

2registered devices

Class II 2

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

SASaudi ArabiaSFDA

12registered imported devices

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

CACanadaMDALL

0active device licences

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 States18 registration records, 3 510(k), 0 PMA, 2 excluded

Brazil2 confirmed, 2 excluded

Saudi Arabia12 confirmed, 0 excluded

Manufacturer names merged into this page: PRODUITS DENTAIRES SA · PRODUITS DENTAIRES S.A. · Produits Dentaires SA · Produits Dentaires S.A · Produits Dentaires Pierre Rolland SAS

FDA 510(k) clearances by year

12005 · K050180

12011 · K111978

12015 · K150423

FDA listed device types

showing 8 of 17

Post, Root Canal 1Retainer, Matrix 1Point, Paper, Endodontic 1Syringe, Periodontic, Endodontic, Irrigating 1Cotton, Roll 1Gutta-Percha 1Floss, Dental 1Strip, Polishing Agent 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K150423	EXPAZEN	2015-07-08
US	K111978	SULCUS BLUE	2011-10-13
US	K050180	EXPA-SYL	2005-02-11
BR	10258199012	IrriFlex	Class II
BR	80745409010	Agulhas de irrigação endodônticas	Class II
SA	ME0000003429SFDAA00043	Abrasive strips	—
SA	ME0000003429SFDAA00041	Transparent strips	—

PRODUITS DENTAIRES SA

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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