Identium Medium Intro pack
EUDAMEDFDA UDIClass IIa (EU MDR)
Identity
- Trade Name
- Identium Medium Intro pack EUDAMEDIdentium FDA UDI
- Generic Name
- Silicone dental impression material FDA UDI
- Device Name
- Identium EUDAMEDIdentium Medium Intro pack FDA UDI
- Model / Reference
- Identium EUDAMED14716 EUDAMEDFDA UDI
- Description
- Identium Medium Intro pack FDA UDI
Identifiers
- Catalog Number
- 14716 FDA UDI
- Primary DI / UDI-DI
- E217147161 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
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Silicone dental impression material
Identium Medium Intro pack by Kettenbach GmbH & Co. KG — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Also classified as Silicone dental impression material.
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | ++E217IMPIDENTIUMFJ | 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 c50a6287-74a6-4eb3-b93c-1909162b24df 61 fields · synced Jul 22, 2026
- FDA UDI aed01135-2c34-4574-9b01-6e134eed91fc 37 fields · synced May 30, 2026