Manufacturer registered with FDA
Tekscan Incorporated
Norwood, MA, United States. Lists 1 dental device type with FDA across 1 registered establishment.
- Device types listed
- 1
- Brands and models
- 6
- 510(k) clearances
- 0as applicant
- Markets registered in
- 524 registrations outside the US
- Establishments
- 1United States
Registered in 5 markets
Where regulators' registries name Tekscan Incorporated 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 | Tekscan Incorporated | 1 device types | — | Below |
| Taiwan | TFDA | Manufacturer | TEKSCAN, INC.TEKSCAN INC. | 12 | 2006–2021 | Pure Global AI |
| South Korea | MFDS | Manufacturer | Tekscan, Inc.Tekscan Inc · Tekscan Inc. · +2 | 10 | 2002–2022 | Pure Global AI |
| Australia | TGA | Manufacturer | Tekscan Incorporated | 1 | 2015–2015 | Pure Global AI |
| Israel | AMAR | Manufacturer | Tekscan, Inc. | 1 | — | 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 Tekscan Incorporated currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Articulation PaperEFH · Class 1 | — | Maker | T-ScanT-Scan EvolutionT-Scan Evolution CoreT-Scan IIIT-Scan NovusT-Scan Novus Core | 2002 |
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 |
|---|---|---|
| TEKSCAN, INC.FDA reg. 1221639 | Norwood, MA, United States | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 1221639). 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.