Panasil initial contact xlight Normal pack
EUDAMEDFDA UDIClass IIa (EU MDR)
Identity
- Trade Name
- Panasil initial contact xlight Normal pack EUDAMEDPanasil FDA UDI
- Generic Name
- Silicone dental impression material FDA UDI
- Device Name
- Panasil EUDAMEDPanasil initial contact X-Light Normal pack FDA UDI
- Model / Reference
- Panasil EUDAMED13401 EUDAMEDFDA UDI
- Description
- Panasil initial contact X-Light Normal pack FDA UDI
Identifiers
- Catalog Number
- 13401 FDA UDI
- Primary DI / UDI-DI
- E217134011 EUDAMEDFDA UDI
- Basic UDI-DI
- ++E217IMPPANASILVA EUDAMED
- 510(k) Number
- K083701 FDA UDI
- FDA Product Code
- ELW FDA UDI
- EMDN Code
- Q01020104 DENTAL IMPRESSION SILICONES 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
Panasil initial contact xlight 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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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 | ++E217IMPPANASILVA | 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 531c53b3-466f-40fc-9335-a359adef007a 61 fields · synced Jun 18, 2026
- FDA UDI 59a10767-fa47-43f7-816b-847717648747 35 fields · synced May 30, 2026