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BIOTECH DENTAL S.A.S

France · Salon De Provence Bouches-Du-Rhone

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Saudi Arabia, 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

9listed device types

Class I 4Class II 5Class III 0

plus 15 registration records and 4 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

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

SASaudi ArabiaSFDA

9registered imported devices

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

CACanadaMDALL

0active device licences

TWTaiwanTFDA

8valid device licences

Class I 4Class II 2Class III 2

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 States15 registration records, 4 510(k), 0 PMA, 893 excluded

Brazil0 confirmed, 133 excluded

Saudi Arabia9 confirmed, 101 excluded

Canada0 confirmed, 169 excluded

Manufacturer names merged into this page: BIOTECH DENTAL SAS · Biotech Dental · BIOTECH DENTAL S.A.S

FDA 510(k) clearances by year

22021 · K212068

12022 · K213997

12024 · K242261

FDA listed device types

showing 8 of 9

Toothbrush, Powered 1Accessories, Implant, Dental, Endosseous 1Centrifuge For Preparation Of Cell Concentrate And/Or Plasma Concentrate 1Dental Implant Surgical Tray 1Lamp, Infrared, Therapeutic Heating 1Sterilization Wrap Containers, Trays, Cassettes & Other Accessories 1Abutment, Implant, Dental, Endosseous 1Aligner, Sequential 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K242261	Accelx Implant System	2024-11-06
US	K213997	Kontact Dental Implant System	2022-07-15
US	K212068	Biotech Dental Kits	2021-11-08
SA	ME0000014702SFDAA00006	regular spoon guide	—
SA	ME0000014702SFDAA00001	short chuck for grinding handle	—

BIOTECH DENTAL S.A.S

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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