Identity
- Trade Name
- ORTOLUX TOP FDA UDI
- Generic Name
- Resin artificial teeth FDA UDI
- Device Name
- ORTOLUX TOP posterior Teeth Shade 66, Mould 32 up. FDA UDI
- Model / Reference
- POSTERIOR TEETH 66/32S FDA UDI
- Description
- ORTOLUX TOP posterior Teeth Shade 66, Mould 32 up. FDA UDI
Identifiers
- Catalog Number
- M36632S FDA UDI
- Primary DI / UDI-DI
- 08435288469218 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 posterior Teeth Shade 66, Mould 32 is a prefabricated dental device designed for mounting on dentures. With its polymer-based material and various sizes, shapes, and colours, it can be customised to suit individual needs. The device has been tested and cleared by regulatory authorities, ensuring safety and efficacy in clinical settings.
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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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Union Dental Sa
Sources (1)
- FDA UDI 838b9429-be48-4eb2-a614-50198fc14a44 35 fields · synced Jul 29, 2026