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Dentotemp
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref DTCA1-5Model Long-term temporary cement
Identity
- Trade Name
- DENTOTEMP EUDAMEDFDA UDI
- Generic Name
- Dental composite resin FDA UDI
- Device Name
- DENTOTEMP EUDAMED
- Model / Reference
- Long-term temporary cement EUDAMEDDTCA1-5 EUDAMEDautomix FDA UDIautomix syringe IntroKit FDA UDI
Identifiers
- Catalog Number
- ECHDTP FDA UDIDTCA1-5 FDA UDI
- Primary DI / UDI-DI
- 03760260221023 EUDAMEDFDA UDI03760260221184 FDA UDI
- Basic UDI-DI
- B-03760260221023 EUDAMED
- FDA Product Code
- EMA FDA UDI
- EMDN Code
- Q0101010202 ROOT CANAL CEMENTS EUDAMED
- GMDN Term
- Dental composite resin FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3275 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
Yes
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Dentotemp by Itena Clinical — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Dental composite resin.
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- Llis — Dentscare Ltda · Class II
- Capo Universal, 6 g — Schütz Dental GmbH · Class II
- 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 (3)
- FDA UDI 13cfe4b4-c2e0-4b01-aa28-529526c7cd42 33 fields · synced Jul 9, 2026
- FDA UDI 68c86ea6-794b-466a-9dbe-9e7c0f2f50b6 33 fields · synced May 30, 2026
- EUDAMED 5a8e185c-e418-432b-a7df-635f2217568c 61 fields · synced Jul 9, 2026