Not currently registered with FDA under this name

Osseous Technologies of America

San Diego, CA, United States. Named as applicant on 1 dental 510(k) clearance between 2008 and 2008. No establishment is registered with FDA under this exact name today.

Device types listed
0
Brands and models
0
510(k) clearances
12008–2008
Markets registered in
35 registrations outside the US
Establishments
0—
2008: 1200020102020

510(k) clearances per year, 2000–2026

Registered in 3 markets

Where regulators' registries name Osseous Technologies of America as the manufacturer or the registration holder of a device.

All markets
United States: 1 clearancesSouth Korea: 3 registrationsTaiwan: 2 registrations
RegisteredHome: United StatesOne marker per market
MarketRegulatorNamed asName on the registryRegistrationsIssuedRecords
United StatesFDAApplicantOsseous Technologies of America1 clearances2008–2008Below
South KoreaMFDSManufacturerOsseous Technologies of AmericaOSSEOUS Technologies of America32007–2008Pure Global AI
TaiwanTFDAManufacturerOSSEOUS TECHNOLOGIES OF AMERICA22008–2011Pure Global AI

Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026

510(k) clearances

Clearances on which FDA names Osseous Technologies of America as the applicant.

Decided510(k)DeviceDevice type
29 Aug 2008K073685OTA COLLAGEN BIOMATERIALNPL Intraoral Animal Source Barrier

Sources

FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record of the most recent filing, which can be a US agent.