Identity
- Trade Name
- Orthodontic retainer FDA UDI
- Generic Name
- Orthodontic retainer FDA UDI
- Device Name
- An orthodontic appliance, bonded or removable, intended to be used on a single patient to maintain teeth in corrected positions during the period of functional adaptation following corrective treatment. This appliance, also referred to as a positioner, is also used to maintain the positions of the teeth and jaws gained by orthodontic procedures. FDA UDI
- Model / Reference
- 014 FDA UDI
- Description
- An orthodontic appliance, bonded or removable, intended to be used on a single patient to maintain teeth in corrected positions during the period of functional adaptation following corrective treatment. This appliance, also referred to as a positioner, is also used to maintain the positions of the teeth and jaws gained by orthodontic procedures. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06972677870146 FDA UDI
- FDA Product Code
- DYT FDA UDI
- GMDN Term
- Orthodontic retainer FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.5525 FDA UDI
- Commercial Distribution
- Not 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
No
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
Orthodontic retainer by Modern Dental Laboratory (DG) Co., Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Modern Dental Laboratory (DG) Co., Ltd.
Sources (1)
- FDA UDI 0295aeca-4ad2-4b4a-8028-a1cff070c6d8 34 fields · synced Jun 8, 2026