Identity
- Trade Name
- Restoration, Resin: Nightguard, Splint FDA UDI
- Generic Name
- Orthodontic retainer FDA UDI
- Model / Reference
- Not Applicable FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06970617030025 FDA UDI
- FDA Product Code
- NSR FDA UDI
- GMDN Term
- Orthodontic retainer FDA UDI
Classification
- Device Class
- N 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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Ultraviolet Light FDA UDI
Category: Orthodontic retainer
Restoration, Resin: Nightguard, Splint by Shenzhen Minghao Dentures Co., Ltd. — Class N — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 N | Pending data |
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Manufacturer
- Manufacturer
- Shenzhen Minghao Dentures Co., Ltd.
Sources (1)
- FDA UDI 0861bf44-e6b8-42f5-8b03-a8c7b7999675 32 fields · synced Jun 8, 2026