Identity
- Trade Name
- CORiTEC PMMA Disc FDA UDI
- Generic Name
- Temporary dental crown/bridge FDA UDI
- Device Name
- CORiTEC PMMA Disc thickness 20mm, diameter 98,5mm, shade A2, with notch FDA UDI
- Model / Reference
- CORiTEC PMMA Disc thickness 20mm, diameter 98,5mm, shade A2, with notch FDA UDI
- Description
- CORiTEC PMMA Disc thickness 20mm, diameter 98,5mm, shade A2, with notch FDA UDI
Identifiers
- Catalog Number
- 5250059821 FDA UDI
- Primary DI / UDI-DI
- D7095250059821 FDA UDI
- 510(k) Number
- K071548 FDA UDI
- FDA Product Code
- EBG FDA UDI
- GMDN Term
- Temporary dental crown/bridge 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
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
Dimensions & Sizes
- Size
- Outer Diameter — 98.5 Millimeter FDA UDIHeight — 20 Millimeter FDA UDI
Category: Temporary dental crown/bridge
CORiTEC PMMA Disc by Merz Dental GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Temporary dental crown/bridge.
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- Pure PMMA Disc — QUEST DENTAL MATERIAL CORPORATION · Class II
- Pure PMMA Disc — QUEST DENTAL MATERIAL CORPORATION · Class II
Cleared under the same submission
K071548 also covers:
- WIELAND ZENO CAO TEMPORARY PMMA DISC, TOOTH-COLORED — Institut Straumann SA
- CORiTEC PMMA Disc — Merz Dental GmbH
- CORiTEC PMMA Disc — Merz Dental GmbH
- CORiTEC PMMA Disc — Merz Dental GmbH
- CORiTEC PMMA Disc — Merz Dental GmbH
- CORiTEC PMMA Disc — Merz Dental GmbH
- CORiTEC PMMA Disc — Merz Dental GmbH
- CORiTEC PMMA Disc — Merz Dental GmbH
- CORiTEC PMMA Disc — Merz Dental GmbH
- Ceramill TEMP — Merz Dental GmbH
- Ceramill TEMP — Merz Dental GmbH
- Ceramill TEMP — 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 c4d62781-b368-413d-80ce-ac10b9e799ff 37 fields · synced May 31, 2026