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Denture, restoration, orthodontic, anti-snoring, orthodontic
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- Denture,restoration,orthodontic,anti-snoring,orthodontic FDA UDI
- Generic Name
- Mandible-repositioning sleep-disordered breathing orthosis FDA UDI
- Model / Reference
- 998 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06972677879989 FDA UDI
- FDA Product Code
- LRK FDA UDINSN FDA UDINSK FDA UDINSL FDA UDINSP FDA UDINSO FDA UDINSJ FDA UDINSQ FDA UDINSR FDA UDINDP FDA UDIDZC FDA UDI
- GMDN Term
- Mandible-repositioning sleep-disordered breathing orthosis FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.5570 FDA UDI872.3980 FDA UDI872.5410 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Partial dentureCustom-made orthopaedic/craniofacial surgical guideDental bridge, polymerOrthodontic retainer
Denture, restoration, orthodontic, anti-snoring, orthodontic by Modern Dental Laboratory (DG) Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID
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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 II | Pending data |
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Manufacturer
- Manufacturer
- Modern Dental Laboratory (DG) Co., Ltd.
Sources (1)
- FDA UDI fc36b3da-d932-4b45-9a2e-03da5730e912 32 fields · synced Jun 6, 2026