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Home›USA›Alpha-Tec Systems, Inc.

Alpha-Tec Systems, Inc.

USA · Irvine
✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Canada, Israel — 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
1listed device types
Class I 1Class II 0Class III 0
plus 1 registration records and 22 510(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
15active device licences
Class II 6Class III 9
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
1registrations
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 States1 registration records, 22 510(k), 0 PMA, 39 excluded
Brazil0 confirmed, 6 excluded
Canada15 confirmed, 3 excluded
Manufacturer names merged into this page: ALPHA-BIO TEC · ALPHA-BIO TEC. LIMITED
Same-named companies — This database also contains companies with near-identical names: ALPHA-BIO TEC. LIMITED. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
USA
City
Irvine

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

FDA 510(k) clearances by year

31983
111988
41989 · K890861
12006 · K053257
32007 · K063769

FDA listed device types

Accessories, Implant, Dental, Endosseous 1

Registration details (sample)

MarketIdentifierNameClass / date
USK063769ALPHA BIO BONE FIXATION SCREW SYSTEM2007-03-30
USK063770ALPHA-BIO ORTHODONTIC FIXATION SCREW SYSTEM2007-03-26
USK063364ALPHA BIO DENTAL IMPLANT SYSTEM2007-03-14
CA74085DENTAL BURS - STAINLESS STEELClass II
CA74086DENTAL DRILLS - TITANIUMClass II
CA74087DENTAL DRILLS - STAINLESS STEELClass II

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