Identity
- Trade Name
- TOTALCEM FDA UDI
- Generic Name
- Dental composite resin FDA UDI
- Model / Reference
- A2 FDA UDI
Identifiers
- Catalog Number
- ECHTLCEM FDA UDI
- Primary DI / UDI-DI
- 03760260221160 FDA UDI
- FDA Product Code
- EMA FDA UDI
- GMDN Term
- Dental composite resin FDA UDI
Classification
- Device Class
- Class II 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
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Dental composite resin
Totalcem by Itena Clinical — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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- OMNICHROMA — TOKUYAMA DENTAL CORPORATION · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Itena Clinical
Sources (2)
- FDA UDI 829d87a5-d180-4700-8721-3510cc29fb1d 33 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 2, 2026