Identity
- Trade Name
- IDODENTINE EUDAMEDFDA UDI
- Generic Name
- Temporary dental crown/bridge FDA UDI
- Device Name
- DENTAL POLYMER BLANK EUDAMEDIDODENTINE DISC 10 LAYERS COLOR A1 98,5/20mm FDA UDI
- Model / Reference
- 4100/A1 EUDAMEDDISC A1 10 LAYERS 98,5/20mm FDA UDI
- Description
- IDODENTINE DISC 10 LAYERS COLOR A1 98,5/20mm FDA UDI
Identifiers
- Catalog Number
- 4100/A1 FDA UDI
- Primary DI / UDI-DI
- 08435288441009 EUDAMEDFDA UDI
- Basic UDI-DI
- 084352884UD-BLANKS6J EUDAMED
- Direct Marketing DI
- 08435288441009 EUDAMED
- 510(k) Number
- K150432 FDA UDI
- FDA Product Code
- EBG FDA UDI
- EMDN Code
- Q01020601,Q01020602,Q01020603,Q01020605 EUDAMED
- GMDN Term
- Temporary dental crown/bridge FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3770 FDA UDI
- Market of Registration
- Spain 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
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Resin artificial teeth
Idodentine by Union Dental S.a. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Resin artificial teeth.
- Resin Teeth / DCL / PE — IVOCLAR VIVADENT AKTIENGESELLSCHAFT · Class II
- Candulor NFC+ — Candulor AG · Class II
- Physioset TCR 6er — Candulor AG · Class II
- Portrait® IPN® Anteriors — Dentsply International · Class II
- artegral life — Merz Dental GmbH · Class II
- Mondial 8i, D4 / M, CE — Kulzer, Inc. · Class II
- Monarch — Wright Health Group , Ltd. · Class II
- Ref-Line — POLIDENT d.o.o. · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 084352884UD-BLANKS6J | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Union Dental S.a.
- EUDAMED SRN
- ES-MF-000003189
Sources (2)
- EUDAMED ad698998-2e69-4a7f-9d58-d8680e5decb5 61 fields · synced Jul 10, 2026
- FDA UDI b805948f-579c-4ee4-a49a-0989b8f7aaf6 35 fields · synced May 30, 2026