Identity
- Trade Name
- TempoCem® Automix FDA UDI
- Generic Name
- Zinc oxide eugenol dental cement FDA UDI
- Device Name
- Temporary cement automix system. The temporary cement that keeps its promise. Content: 2 syringes @ 5 ml paste, accessories. FDA UDI
- Model / Reference
- 212129 FDA UDI
- Description
- Temporary cement automix system. The temporary cement that keeps its promise. Content: 2 syringes @ 5 ml paste, accessories. FDA UDI
Identifiers
- Catalog Number
- 212129 FDA UDI
- Primary DI / UDI-DI
- EDMG2121290 FDA UDI
- 510(k) Number
- K110759 FDA UDI
- FDA Product Code
- EMB FDA UDI
- GMDN Term
- Zinc oxide eugenol dental cement FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.3275 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
Yes
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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Zinc oxide eugenol dental cement
TempoCem® Automix by DMG Chemisch-Pharmazeutische Fabrik GmbH — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Zinc oxide eugenol dental cement.
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Cleared under the same submission
K110759 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 I | Pending data |
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Manufacturer
- Manufacturer
- DMG Chemisch-Pharmazeutische Fabrik GmbH
Sources (1)
- FDA UDI b97f0724-2dc7-4ce1-ab67-7c1f9224e3fc 37 fields · synced Jun 6, 2026