Identity
- Trade Name
- PRO Resins Denture Fix FDA UDI
- Generic Name
- Dental prosthesis-component adhesive FDA UDI
- Device Name
- PRO Resins Denture Fix 8g FDA UDI
- Model / Reference
- 019.3233 FDA UDI
- Description
- PRO Resins Denture Fix 8g FDA UDI
Identifiers
- Catalog Number
- 019.3233 FDA UDI
- Primary DI / UDI-DI
- 04260635981365 FDA UDI
- 510(k) Number
- K212541 FDA UDI
- FDA Product Code
- EBI FDA UDIKLE FDA UDI
- GMDN Term
- Dental prosthesis-component adhesive FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3760 FDA UDI872.3200 FDA UDI
- Commercial Distribution
- 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
Category: Dental prosthesis-component adhesive
PRO Resins Denture Fix by DeltaMed GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental prosthesis-component adhesive.
- ZrP Syringe Kit — Vista Dental · Class II
- Henry Schein — HENRY SCHEIN, INC. · Class II
- Polibond 30 ml — Zirkonzahn GmbH · Class II
- 3Delta Denture Fix — DeltaMed GmbH · Class II
Cleared under the same submission
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 |
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Manufacturer
- Manufacturer
- DeltaMed GmbH
Sources (1)
- FDA UDI 0aae64d4-e155-46d3-a178-d89ea50da510 36 fields · synced May 30, 2026