Identity
- Trade Name
- artegral HD FDA UDI
- Generic Name
- Resin artificial teeth FDA UDI
- Device Name
- posteriors; shade BL4; size XL; upper jaw FDA UDI
- Model / Reference
- posteriors; shade BL4; size XL; upper jaw FDA UDI
- Description
- posteriors; shade BL4; size XL; upper jaw FDA UDI
Identifiers
- Catalog Number
- 1973190 FDA UDI
- Primary DI / UDI-DI
- D7091973190 FDA UDI
- 510(k) Number
- K120404 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
No
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Resin artificial teeth
artegral HD by Merz Dental GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K120404 also covers:
- Polystar Selection EDITION HD — Merz Dental GmbH
- Polystar Selection EDITION HD — Merz Dental GmbH
- Polystar Selection EDITION HD — Merz Dental GmbH
- Polystar Selection EDITION HD — Merz Dental GmbH
- Polystar Selection EDITION HD — Merz Dental GmbH
- Polystar Selection EDITION HD — Merz Dental GmbH
- Polystar Selection EDITION HD — Merz Dental GmbH
- Polystar Selection EDITION HD — Merz Dental GmbH
- Polystar Selection EDITION HD — Merz Dental GmbH
- Polystar Selection EDITION HD — Merz Dental GmbH
- Polystar Selection EDITION HD — Merz Dental GmbH
- Polystar Selection EDITION HD — Merz Dental GmbH
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
- Merz Dental GmbH
Sources (1)
- FDA UDI c562f65d-1adc-4f95-bb55-c5fb508b3f49 36 fields · synced May 31, 2026