Home›Spain›B.T.I. BIOTECHNOLOGY INSTITUTE, S.L.

B.T.I. BIOTECHNOLOGY INSTITUTE, S.L.

Spain · Minano

✓ Record-verifiedregistrations found in 6 markets

This company has registrations in United States, Saudi Arabia, Canada, Taiwan, Singapore, Hong Kong — 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

33listed device types

Class I 25Class II 8Class III 0

plus 47 registration records and 15 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

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

SASaudi ArabiaSFDA

1registered imported devices

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

CACanadaMDALL

7active device licences

Class II 5Class III 2

33 including historic records

TWTaiwanTFDA

3valid device licences

Class I 1Class II 1Class III 1

SGSingaporeHSA SMDR

2device registrations

CLASS B 1CLASS C 1

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

2valid listings

IVD C 2

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 States47 registration records, 15 510(k), 0 PMA, 72 excluded

Brazil0 confirmed, 6 excluded

Saudi Arabia1 confirmed, 9 excluded

Canada7 confirmed, 7 excluded

Manufacturer names merged into this page: B.T.I. BIOTECHNOLOGY INSTITUTE, S.L. · B.T.I. BIOTECHNOLOGY INSTITUTE S.L. · BIOTECHNOLOGY MEDICAL SERVICES EUROPE SL. (BMS EUROPE)

FDA 510(k) clearances by year

12003

12005

22006

12007

12009

12010

12016

12018

12021

22022

22023

12024

FDA listed device types

showing 8 of 33

Curette, Periodontic 1Scissors, Surgical Tissue, Dental 1Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use 1Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use 1Handle, Scalpel 1Dental Implant Surgical Tray 1Accessories, Implant, Dental, Endosseous 1Blade, Scalpel 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K240262	BTI Interna 3.0 Dental Implant System UnicCa®	2024-10-10
US	K232750	BTI Interna Prosthetic Components	2023-12-08
US	K231827	BTI Dental Implant System UnicCa® Aesthetic Post Abutments	2023-09-15
SA	ME0000000753SFDAA00001	BMS PRODUCT	—
CA	87624	BTI DIAMOND DISCS	Class II
CA	87737	BTI HEMISECTION SURGICAL DRILL	Class II
CA	88292	BTI INTERNA DENTAL IMPLANTS	Class III

B.T.I. BIOTECHNOLOGY INSTITUTE, S.L.

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