Not currently registered with FDA under this name

Treace Medical, Inc.

Memphis, TN, United States. Named as applicant on 3 dental 510(k) clearances between 1983 and 1987. No establishment is registered with FDA under this exact name today.

Device types listed
0
Brands and models
0
510(k) clearances
31983–1987
Markets registered in
24 registrations outside the US
Establishments
0—
1983: 21987: 119801990200020102020

510(k) clearances per year, 1980–2026

Registered in 2 markets

Where regulators' registries name Treace Medical, Inc. as the manufacturer or the registration holder of a device.

All markets
United States: 3 clearancesTaiwan: 4 registrations
RegisteredHome: United StatesOne marker per market
MarketRegulatorNamed asName on the registryRegistrationsIssuedRecords
United StatesFDAApplicantTreace Medical, Inc.3 clearances1983–1987Below
TaiwanTFDAManufacturerTREACE MEDICAL, INC.41986–1986Pure 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 Treace Medical, Inc. as the applicant.

Decided510(k)DeviceDevice type
27 May 1987K870765CANNULATED INSTRUMENT CLEANERSEKW Endodontic Broach
26 Jan 1983K823913SOFT GRIP UNI-HANDLEEJB Dental Instrument Handle
21 Jan 1983K823914EXPLORER TIPEKB Operative Explorer

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.