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Basic Dental Implant Systems, Inc.

USA · Albuquerque

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Canada, 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

7listed device types

Class I 6Class II 1Class III 0

plus 9 registration records and 6 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

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

0active device licences

2 including historic records

TWTaiwanTFDA

3valid device licences

Class I 1Class 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 States9 registration records, 6 510(k), 0 PMA, 6 excluded

Brazil0 confirmed, 1 excluded

Canada0 confirmed, 2 excluded

Manufacturer names merged into this page: Basic Dental Implant Systems, Inc. · BASIC DENTAL IMPLANT SYSTEMS INC.

FDA 510(k) clearances by year

32001 · K013682

12002 · K022912

22008 · K082749

FDA listed device types

Bur, Dental 1Punch, Biopsy, Surgical 1Crown, Preformed 1Accessories, Implant, Dental, Endosseous 1Handle, Instrument, Dental 1Gauge, Depth, Instrument, Dental 1Implant, Endosseous, Root-Form 1

Market	Identifier	Name	Class / date
US	K082749	OMNI-TIGHT	2008-12-04
US	K072595	OMNI-TIGHT	2008-05-09
US	K022912	POST AND CORE - THIN FOR THE BASIC DENTAL IMPLANT SYSTEM	2002-09-20

Basic Dental Implant Systems, 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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