Identity
- Trade Name
- Mucopren FDA UDI
- Generic Name
- Denture reliner, elastic, long-term FDA UDI
- Device Name
- Mucopren Soft Basic Set + Applyfix 4 disp. gun FDA UDI
- Model / Reference
- 28106 FDA UDI
- Description
- Mucopren Soft Basic Set + Applyfix 4 disp. gun FDA UDI
Identifiers
- Catalog Number
- 28106 FDA UDI
- Primary DI / UDI-DI
- E217281061 FDA UDI
- 510(k) Number
- K983357 FDA UDI
- FDA Product Code
- EBI FDA UDI
- GMDN Term
- Denture reliner, elastic, long-term FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3760 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Mucopren by Kettenbach GmbH & Co. KG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Kettenbach GmbH & Co. KG
Sources (1)
- FDA UDI 97b6e060-494b-4730-870a-c5d7580941d4 38 fields · synced May 30, 2026