Manufacturer registered with FDA
Microtech
Santa Ana, CA, United States. Lists 1 dental device type with FDA across 1 registered establishment, and holds 1 510(k) clearance as applicant.
- Device types listed
- 1
- Brands and models
- 1
- 510(k) clearances
- 12002–2002
- Markets registered in
- 23 registrations outside the US
- Establishments
- 1United States
510(k) clearances per year, 2000–2026
Registered in 2 markets
Where regulators' registries name Microtech as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Microtech | 1 clearances | 2002–2002 | Below |
| South Korea | MFDS | Manufacturer | MicrotechMICROTECH | 3 | 2004–2006 | Pure 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
Devices listed with FDA
What Microtech currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Dental Air-Powered HandpieceEFB · Class 1 | Dental handpieces | Maker | Dentex | 2007 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names Microtech as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 22 Oct 2002 | K022535 | MICROTECH PUSH BUTTON HANDPIECE, MODEL MHS-A100 | EFB Dental Air-Powered Handpiece |
Some of these clearances are listed with FDA today by another company: Osseo Scientific, LLC (1).
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| MICROTECHFDA reg. 2032725 | Santa Ana, CA, United States | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9052357). 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.