Identity
- Trade Name
- Denture FDA UDI
- Generic Name
- Dental casting noble alloy FDA UDI
- Device Name
- Noble metal restorations are crowns, bridges, inlays, and onlays that are manufactured as finished products from noble metals. FDA UDI
- Model / Reference
- 004 FDA UDI
- Description
- Noble metal restorations are crowns, bridges, inlays, and onlays that are manufactured as finished products from noble metals. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08936214220045 FDA UDI
- FDA Product Code
- NSJ FDA UDI
- GMDN Term
- Dental casting noble alloy 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
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: Dental casting noble alloyCustom-made dental crown, metalGold dental inlay
Denture by Aceso Dental Laboratory Company Limited — Class N — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Gold dental inlay.
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- Restoration — Modern Dental Laboratory (DG) Co., Ltd. · N
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- Restoration, splint — Modern Dental Laboratory (DG) Co., Ltd. · N
- Restoration, denture — Modern Dental Laboratory (DG) Co., Ltd. · N
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
- Aceso Dental Laboratory Company Limited
Sources (1)
- FDA UDI d4cb60c7-5197-4d24-8580-753a1ef06ce9 33 fields · synced May 30, 2026