Identity
- Trade Name
- ORTOLUX TOP FDA UDI
- Generic Name
- Resin artificial teeth FDA UDI
- Device Name
- ORTOLUX TOP posterior Teeth Shade D4, Mould 54 up. FDA UDI
- Model / Reference
- POSTERIOR TEETH D4/54S FDA UDI
- Description
- ORTOLUX TOP posterior Teeth Shade D4, Mould 54 up. FDA UDI
Identifiers
- Catalog Number
- M3D454S FDA UDI
- Primary DI / UDI-DI
- 08435288437743 FDA UDI
- 510(k) Number
- K070591 FDA UDI
- FDA Product Code
- ELM FDA UDI
- GMDN Term
- Resin artificial teeth FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3590 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
No
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
Category: Resin artificial teeth
Ortolux Top by Union Dental Sa — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K070591 also covers:
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
- Union Dental Sa
Sources (1)
- FDA UDI 5edc9bbd-26ec-4e2e-afbd-fb7a8cb87676 35 fields · synced Jun 8, 2026