Manufacturer registered with FDA
ORTHO-TAIN, Inc.
Toa Alta, PR, United States. Lists 3 dental device types with FDA across 1 registered establishment, and holds 2 510(k) clearances as applicant.
- Device types listed
- 3
- Brands and models
- 14
- 510(k) clearances
- 21995–1998
- Markets registered in
- 543 registrations outside the US
- Establishments
- 1United States
510(k) clearances per year, 1990–2026
Registered in 5 markets
Where regulators' registries name ORTHO-TAIN, Inc. 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 | ORTHO-TAIN, Inc. | 2 clearances | 1995–1998 | Below |
| Canada | Health Canada | Registration holder | ORTHO-TAIN, INC. | 33 | 2005–2016 | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | ORTHO-TAIN, INC. | 7 | — | Pure Global AI |
| Australia | TGA | Manufacturer | Ortho-Tain Inc | 2 | 2018–2018 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | ORTHO-TAIN, INC | 1 | 2011–2011 | 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 ORTHO-TAIN, Inc. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Orthodontic Material BandDYO · Class 1 | Orthodontic wires & bands | Maker | CLASS III GUIDEHABIT-CORRECTORHAWLEY-FORMINTERIM "G" RETAINERSNORE-CURESOFTEE APPLIANCESPORTGUARDSTOP SHOCK | 2001 |
| Orthodontic WireDZC · Class 1 | Orthodontic wires & bands | Maker | PERFIT BUMPER | 2001 |
| Orthodontic Preformed BandECM · Class 1 | Orthodontic wires & bands | Maker | NITE-GUIDE PREFORMED ACTIVATOROCCLUS-O-GUIDEOCCLUS-O-GUIDE PREFORMED ACTIVATORORTHO-TAINORTHO-TAIN PREFORMED POSITIONER | 1992 |
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 |
|---|---|---|
| ORTHO-TAIN, INC.FDA reg. 2649784 | Toa Alta, PR, United States | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9914028). 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.