Is this your brand? Sign in to claim ownership.
Sign in to claim this brandOrtho-Tain, Inc
US
Last updated May 23, 2026
What Ortho-Tain, Inc makes
Ortho-Tain, Inc manufactures orthodontic retainers, including the KGuard Pro, designed to maintain tooth alignment after braces treatment.
The company’s products are regulated under FDA Class I and Class II categories, with records available in the FDA’s 510(k) and UDI databases. The manufacturer is based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Ortho-Tain, Inc manufacture?
Ortho-Tain, Inc specializes in orthodontic retainers, such as the KGuard Pro. These devices are designed to help patients maintain tooth alignment after completing orthodontic treatment like braces. The focus is on post-treatment stabilization, ensuring long-term results.
Where is Ortho-Tain, Inc based, and does that affect its regulatory standing?
Ortho-Tain, Inc is based in the United States. Since the company operates within the U.S., its devices are subject to FDA regulations. The FDA classifies its orthodontic retainers as either Class I or Class II, depending on specific design and risk factors, which determines the regulatory pathway for authorization.
Which regulatory databases list Ortho-Tain, Inc’s devices?
Ortho-Tain, Inc’s devices are recorded in the FDA’s 510(k) premarket notification database and the FDA’s Unique Device Identifier (UDI) system. The 510(k) database tracks submissions for devices deemed substantially equivalent to legally marketed alternatives, while the UDI system ensures traceability and identification of medical devices in commerce.
How are Ortho-Tain, Inc’s orthodontic retainers classified under FDA regulations?
Ortho-Tain, Inc’s orthodontic retainers fall under FDA Class I or Class II classifications. Class I devices generally pose minimal risk and may require general controls, while Class II devices involve a higher risk and require special controls to ensure safety and effectiveness. The classification depends on factors like the device’s intended use and potential harm if misused.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- —
- —
- —
- —
- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 090557638
Catalogue (69)
Page 2 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Ortho-Tain, Inc | INTERIM "G" | FDA UDI | Class I | Active |
| Ortho-Tain, Inc | SOFTEE | FDA UDI | Class I | Active |
| Ortho-Tain, Inc | INTERIM "G" | FDA UDI | Class I | Active |
| Ortho-Tain, Inc | HABIT CORRECTOR | FDA UDI | Class I | Active |
| Ortho-Tain, Inc | CLASS III | FDA UDI | Class I | Active |
| Ortho-Tain, Inc | ORTHO TAIN POSITIONER | FDA UDI | Class I | Active |
| Ortho-Tain, Inc | HABIT CORRECTOR | FDA UDI | Class I | Active |
| Ortho-Tain, Inc | ORTHO-TAIN ORTHO-T | FDA UDI | Class I | Active |
| Ortho-Tain, Inc | ORTHO TAIN POSITIONER | FDA UDI | Class I | Active |
| KGuard Pro | MOUTHGUARD | FDA UDI | Class I | Unknown |
| Ortho-Tain, Inc | OCCLUS-O-GUIDE | FDA UDI | Class I | Active |
| Ortho-Tain, Inc | INTERIM "G" | FDA UDI | Class I | Active |
| Ortho-Tain, Inc | ORTHO TAIN POSITIONER | FDA UDI | Class I | Active |
| Ortho-Tain, Inc | HABIT CORRECTOR | FDA UDI | Class I | Active |
| KGuard Pro | MOUTHGUARD | FDA UDI | Class I | Active |
| Ortho-Tain, Inc | HABIT CORRECTOR | FDA UDI | Class I | Active |
| KGuard Pro | MOUTHGUARD | FDA UDI | Class I | Active |
| Snore-Cure Anti-Snoring Appliance | K980952 | FDA 510(k) | Class II | Active |
| Nite-Guide | K931615 | FDA 510(k) | Class I | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.