Identity
- Trade Name
- Silginat Refill pack EUDAMEDSilginat FDA UDI
- Generic Name
- Silicone dental impression material FDA UDI
- Device Name
- Silginat EUDAMEDSilginat Refill pack FDA UDI
- Model / Reference
- 14713 EUDAMEDFDA UDI14770 EUDAMED
- Description
- Silginat Refill pack FDA UDI
Identifiers
- Catalog Number
- 14713 FDA UDI
- Primary DI / UDI-DI
- E217147131 EUDAMEDFDA UDIE217147701 EUDAMED
- Basic UDI-DI
- ++E217IMPSILGINATMH EUDAMED
- 510(k) Number
- K082157 FDA UDI
- FDA Product Code
- ELW FDA UDI
- EMDN Code
- Q01020199 DENTAL IMPRESSION MATERIALS - OTHER EUDAMED
- GMDN Term
- Silicone dental impression material FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3660 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
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: Silicone dental impression material
Silginat Refill pack by Kettenbach GmbH & Co. KG — Class IIa — 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 | ++E217IMPSILGINATMH | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Kettenbach GmbH & Co. KG
- EUDAMED SRN
- DE-MF-000005014
Sources (3)
- EUDAMED bfb08ad8-88a2-49e9-bc89-db6987ec0bd6 61 fields · synced Jul 29, 2026
- EUDAMED e8ed5dec-f7bc-476e-b8a5-c2cdcbe8cc1b 61 fields · synced May 19, 2026
- FDA UDI 6730733e-d3cc-4d49-853a-1d7ee4e12d02 35 fields · synced May 30, 2026