Identity
- Trade Name
- PREORTHO Pre-Orthodontic Device FDA UDI
- Generic Name
- Orthodontic progressive aligner FDA UDI
- Device Name
- An orthodontic appliance, typically supplied in series intended to be worn while sleeping and for about one hour during the day, designed to influence the shape and or function of the stomatognathic system to correct malocclusions, e.g., underbites, overbites, cross bites, open bites, crooked teeth, and or structural flaws of teeth and or jaws. The device is self-removable, a post-treatment orthodontic retainer positioner may be included with the device. This is a reusable device. FDA UDI
- Model / Reference
- T1-SS FDA UDI
- Description
- An orthodontic appliance, typically supplied in series intended to be worn while sleeping and for about one hour during the day, designed to influence the shape and or function of the stomatognathic system to correct malocclusions, e.g., underbites, overbites, cross bites, open bites, crooked teeth, and or structural flaws of teeth and or jaws. The device is self-removable, a post-treatment orthodontic retainer positioner may be included with the device. This is a reusable device. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04573443678809 FDA UDI
- FDA Product Code
- KMY FDA UDI
- GMDN Term
- Orthodontic progressive aligner FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.5525 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Orthodontic progressive aligner
PREORTHO Pre-Orthodontic Device by Forest-One Co., Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Reveal® Clear Aligners — Ortho Organizers, Inc. · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Forest-One Co., Ltd.
Sources (1)
- FDA UDI 50b2cca1-a7a8-47b0-9a42-7fa5960dfc43 34 fields · synced May 31, 2026