Identity
- Trade Name
- Spring Retainer 4X4 - Upper FDA UDI
- Generic Name
- Orthodontic retainer FDA UDI
- Model / Reference
- 5100178 FDA UDI
Identifiers
- Primary DI / UDI-DI
- D82851001780 FDA UDI
- FDA Product Code
- DYJ FDA UDI
- GMDN Term
- Orthodontic retainer FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.5410 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Orthodontic retainer
A comprehensive 2-3 paragraph SEO description written in clear, natural language. The Spring Retainer 4X4 is an orthodontic appliance designed to maintain teeth in corrected positions during functional adaptation following corrective treatment. This device is intended for single patient use and is not a combination product or kit.
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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
- Five Star Orthodontic Laboratory & Supply, Inc.
Sources (1)
- FDA UDI fe80a72a-f5cb-47c4-ac1c-d9670522b088 32 fields · synced Jul 25, 2026