Identity
- Trade Name
- Bissgabel partiell (2 Stück) EUDAMEDaccessory FDA UDI
- Generic Name
- Facebow FDA UDI
- Device Name
- jaw relation facebow and accessories / Kieferrelationsbestimmung EUDAMED
- Model / Reference
- 217611 EUDAMEDBite fork partial, 2pcs FDA UDI
Identifiers
- Catalog Number
- 217611 FDA UDI
- Primary DI / UDI-DI
- E4942176111 EUDAMEDE4942176112 FDA UDI
- Basic UDI-DI
- ++E494ARTEX7L EUDAMED
- FDA Product Code
- KCR FDA UDI
- EMDN Code
- L15900699 DENTAL MATERIAL PROCESSING INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Facebow FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.3220 FDA UDI
- Market of Registration
- Austria EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Bissgabel partiell (2 Stück) by Amann Girrbach AG — 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 | ++E494ARTEX7L | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Amann Girrbach AG
- EUDAMED SRN
- AT-MF-000000252
Sources (2)
- EUDAMED 0f553c0a-1002-40d0-af89-8d7714b7fb48 61 fields · synced Oct 6, 2026
- FDA UDI d7747a4c-a19d-471f-b583-05376efd23d4 34 fields · synced May 30, 2026