Identity
- Trade Name
- BISSWÄLLE PINK (X-HART) EUDAMEDNA FDA UDI
- Generic Name
- Denture clasp, metal, custom-made FDA UDI
- Device Name
- Bisswälle EUDAMEDPreformed bite rims, pink (x-hard), 100pc. FDA UDI
- Model / Reference
- 82350 EUDAMEDFDA UDI
- Description
- Preformed bite rims, pink (x-hard), 100pc. FDA UDI
Identifiers
- Primary DI / UDI-DI
- +EGEB82350 EUDAMEDEGEB82350 FDA UDI
- Basic UDI-DI
- 42518579BissWallHan54 EUDAMED
- FDA Product Code
- EGD FDA UDI
- EMDN Code
- Q01020199 DENTAL IMPRESSION MATERIALS - OTHER EUDAMED
- GMDN Term
- Denture clasp, metal, custom-made FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.6890 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
No
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
Category: Silicone dental impression material
Bisswälle Pink (x-Hart) by Gebdi Dental-Products GmbH — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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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 | 42518579BissWallHan54 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- gebdi DENTAL-PRODUCTS GmbH
- EUDAMED SRN
- DE-MF-000005566
Sources (2)
- EUDAMED 5c4a32a5-302e-4a65-a99f-b6b054275d47 61 fields · synced Jul 28, 2026
- FDA UDI 60ef7181-cf13-494d-9299-9de88a44d312 33 fields · synced May 30, 2026