Identity
- Trade Name
- DiaCemTempNE FDA UDI
- Generic Name
- Ethoxy benzoic acid dental cement FDA UDI
- Device Name
- This product is a non-eugenol type dental adhesive cement that corresponds to type 1 (for temporary cementation) according to the classification of ISO3107. Zinc oxide reacts with 2-ethoxybenzoic acid to have relatively low adhesion and strength and is used for temporary bonding. FDA UDI
- Model / Reference
- DiaCemTempNE 10g (B type) FDA UDI
- Description
- This product is a non-eugenol type dental adhesive cement that corresponds to type 1 (for temporary cementation) according to the classification of ISO3107. Zinc oxide reacts with 2-ethoxybenzoic acid to have relatively low adhesion and strength and is used for temporary bonding. FDA UDI
Identifiers
- Catalog Number
- A2003-3102 FDA UDI
- Primary DI / UDI-DI
- 08806383585897 FDA UDI
- FDA Product Code
- EMB FDA UDI
- GMDN Term
- Ethoxy benzoic acid 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Ethoxy benzoic acid dental cement
DiaCemTempNE by DiaDent Group International — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- DiaDent Group International
Sources (1)
- FDA UDI ac8157d7-e519-4848-a4e3-7e1f6c2d3e33 35 fields · synced May 30, 2026