Identity
- Trade Name
- Identium Light Fast Sample EUDAMEDIdentium FDA UDI
- Generic Name
- Silicone dental impression material FDA UDI
- Device Name
- Identium EUDAMEDIdentium Light Fast Sample FDA UDI
- Model / Reference
- 13710 EUDAMEDFDA UDIIdentium EUDAMED
- Description
- Identium Light Fast Sample FDA UDI
Identifiers
- Catalog Number
- 13710 FDA UDI
- Primary DI / UDI-DI
- E217137101 EUDAMEDFDA UDI
- Basic UDI-DI
- ++E217IMPIDENTIUMFJ EUDAMED
- 510(k) Number
- K092867 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
- Not 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
Identium by Kettenbach GmbH & Co. KG — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Cleared under the same submission
K092867 also covers:
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Kettenbach GmbH & Co. KG
Sources (2)
- FDA UDI 76c6e784-0c31-489e-9a82-fa602c17598f 38 fields · synced Oct 8, 2026
- EUDAMED 402e9a93-b56a-4cc6-b92e-4af4c5e2a49a 61 fields · synced Oct 8, 2026