Identity
- Trade Name
- DentaIBT EUDAMEDFDA UDI
- Generic Name
- Dental appliance fabrication material, resin FDA UDI
- Device Name
- DentaIBT EUDAMED
- Model / Reference
- 03746 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 09359215000055 EUDAMEDFDA UDI
- Basic UDI-DI
- 93592150IBT2E EUDAMED
- FDA Product Code
- QJJ FDA UDI
- EMDN Code
- Q0102050199 DENTISTRY RESINS - OTHER EUDAMED
- GMDN Term
- Dental appliance fabrication material, resin FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.5410 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
DentaIBT by Asiga — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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 | 93592150IBT2E | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Asiga
- EUDAMED SRN
- AU-MF-000012099
- Authorised Representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Sources (2)
- EUDAMED b2746ae7-5836-4601-a9f7-d2f42befdf42 61 fields · synced Jun 18, 2026
- FDA UDI 6b527ef2-a942-49cf-9c9e-4fa92aa40cca 32 fields · synced May 25, 2026