Identity
- Trade Name
- Visalys Temp EUDAMEDFDA UDI
- Generic Name
- Temporary dental crown/bridge FDA UDI
- Device Name
- Visalys Temp EUDAMEDVisalys Temp A1 Normal pack FDA UDI
- Model / Reference
- Visalys Temp EUDAMED13780 EUDAMEDFDA UDI
- Description
- Visalys Temp A1 Normal pack FDA UDI
Identifiers
- Catalog Number
- 13780 FDA UDI
- Primary DI / UDI-DI
- E217137801 EUDAMEDFDA UDI
- Basic UDI-DI
- ++E217VTEMP8X EUDAMED
- 510(k) Number
- K122039 FDA UDI
- FDA Product Code
- EBG FDA UDI
- EMDN Code
- Q0101010203 TEMPORARY DENTAL CEMENTS EUDAMED
- GMDN Term
- Temporary dental crown/bridge FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3770 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
Yes
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
Visalys Temp by Kettenbach GmbH & Co. KG — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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 | ++E217VTEMP8X | 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 56e1f16a-5075-4373-abff-10747680fe75 61 fields · synced Jun 6, 2026
- FDA UDI e3e834ae-3fd0-4fa5-b390-6e25b47b9309 35 fields · synced May 30, 2026