Manufacturer registered with FDA
Dentech Corp.
TOKYO, Japan. Lists 21 dental device types with FDA across 1 registered establishment.
- Device types listed
- 21
- Brands and models
- 21
- 510(k) clearances
- 0as applicant
- Markets registered in
- 516 registrations outside the US
- Establishments
- 1Japan
Registered in 5 markets
Where regulators' registries name Dentech Corp. 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 | Dentech Corp. | 21 device types | — | Below |
| Taiwan | TFDA | Manufacturer | DENTECH CORPORATION | 13 | 2005–2021 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | DENTECH CORPORATION | 1 | 2005–2005 | Pure Global AI |
| Israel | AMAR | Manufacturer | DENTECH CORPORATION | 1 | — | Pure Global AI |
| Peru | DIGEMID | Manufacturer | DENTECH CORPORATION | 1 | 2025–2025 | 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 Dentech Corp. currently lists, by FDA device type, with the brand and model names on the listing.
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| DENTECH CORP.FDA reg. 9611450 | TOKYO, Japan | Contract manufacturer, Manufacturer, Repacker / relabeler |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 8030336). 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.