Identity
- Trade Name
- LuxaCrown FDA UDI
- Generic Name
- Dental composite resin FDA UDI
- Device Name
- Self-curing Composite for the fabrication of semipermanent crowns and bridges. The material is mixed automatically. Content: 1 cartridge @ 50 ml paste, accessories. Color: B1. FDA UDI
- Model / Reference
- 120974 FDA UDI
- Description
- Self-curing Composite for the fabrication of semipermanent crowns and bridges. The material is mixed automatically. Content: 1 cartridge @ 50 ml paste, accessories. Color: B1. FDA UDI
Identifiers
- Catalog Number
- 120974 FDA UDI
- Primary DI / UDI-DI
- EDMG1209740 FDA UDI
- FDA Product Code
- POW FDA UDI
- GMDN Term
- Dental composite resin FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3770 FDA UDI
- Commercial Distribution
- 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
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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Dental composite resin
LuxaCrown by DMG Chemisch-Pharmazeutische Fabrik GmbH — Class II — 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 II | Pending data |
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Manufacturer
- Manufacturer
- DMG Chemisch-Pharmazeutische Fabrik GmbH
Sources (1)
- FDA UDI 30e50c35-1f88-4417-bab6-4a207191f98e 36 fields · synced Jun 8, 2026