HomeUSAAdvanced Ortho-Technology, Inc.

Advanced Ortho-Technology, Inc.

USA · Tuckahoe
✓ 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
7510(k) clearances
Class I 0Class II 0Class III 0
plus 0 registration records and 7 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
3registered devices
Class II 3
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
48registered 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 States0 registration records, 7 510(k), 0 PMA, 110 excluded
Brazil3 confirmed, 35 excluded
Saudi Arabia48 confirmed, 11 excluded
Canada0 confirmed, 13 excluded
Manufacturer names merged into this page: Ortho Technology, Inc. · Ortho Technology, Inc

Company information

Country
USA
City
Tuckahoe

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

11985 · K854344
21986 · K861937
12000 · K000358
12005 · K051751
12007 · K073045
12012 · K112707

Registration details (sample)

MarketIdentifierNameClass / date
USK112707GENERATION C AESTHETIC SELF-LIGATING BRACKET SYSTEM2012-01-13
USK073045SAPPHIRE CERAMIC BRACKET2007-12-18
USK051751EQUA-PULL SAFETY RELEASE MODULE2005-07-22
BR80743680005Light-Cure Band CementClass II
BR80743680004ElastomericClass II
BR80743680006PUREClass II
SAME0000009463SFDAA00148Bionic
SAME0000009463SFDAA00152Sensation M

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