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Ortolux Top
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref M3B152SModel Artificial Teeth
Identity
- Trade Name
- ORTOLUX TOP EUDAMEDFDA UDI
- Generic Name
- Resin artificial teeth FDA UDI
- Device Name
- ORTOLUX TOP posterior Teeth Shade B1, Mould 52 up. FDA UDI
- Model / Reference
- Artificial Teeth EUDAMEDM3B152S EUDAMEDPOSTERIOR TEETH B1/52S FDA UDI
- Description
- ORTOLUX TOP posterior Teeth Shade B1, Mould 52 up. FDA UDI
Identifiers
- Catalog Number
- M3B152S FDA UDI
- Primary DI / UDI-DI
- 08435288436043 EUDAMEDFDA UDI
- Basic UDI-DI
- 084352884UD-TEETHVS EUDAMED
- 510(k) Number
- K070591 FDA UDI
- FDA Product Code
- ELM FDA UDI
- EMDN Code
- Q01020601,Q01020602,Q01020603,Q01020605 EUDAMED
- GMDN Term
- Resin artificial teeth FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3590 FDA UDI
- Market of Registration
- Spain EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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 — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Cleared under the same submission
K070591 also covers:
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Union Dental Sa
Sources (2)
- FDA UDI 64af3b5e-3317-41d5-a3bc-5d3e85678ba7 35 fields · synced Jul 21, 2026
- EUDAMED c0a811ee-4c93-4139-9a88-b93674b1c4be 61 fields · synced Jul 21, 2026