Identity
- Trade Name
- Silginat Strawberry Normal pack EUDAMEDSilginat FDA UDI
- Generic Name
- Silicone dental impression material FDA UDI
- Device Name
- Silginat EUDAMEDSilginat Strawberry Normal pack FDA UDI
- Model / Reference
- 13826 EUDAMEDFDA UDI
- Description
- Silginat Strawberry Normal pack FDA UDI
Identifiers
- Catalog Number
- 13826 FDA UDI
- Primary DI / UDI-DI
- E217138261 EUDAMEDFDA UDI
- 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 Strawberry Normal 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 (2)
- EUDAMED 0c89cad5-82cf-410c-820e-0d52735ad526 61 fields · synced Oct 6, 2026
- FDA UDI 249385bf-d4ed-4ac5-827b-d87051047978 35 fields · synced May 30, 2026