Identity
- Trade Name
- Polibond 30 ml FDA UDI
- Generic Name
- Dental prosthesis-component adhesive FDA UDI
- Device Name
- Content: Liquid for bonding Zirkonzahn Abro Basic Mono, Abro Basic Multistratum and Denture Gingiva Basic Mono resins as well as for polishing Zirkonzahn Multistratum Flexible and Temp Premium Flexible resins. FDA UDI
- Model / Reference
- CPAD0101 FDA UDI
- Description
- Content: Liquid for bonding Zirkonzahn Abro Basic Mono, Abro Basic Multistratum and Denture Gingiva Basic Mono resins as well as for polishing Zirkonzahn Multistratum Flexible and Temp Premium Flexible resins. FDA UDI
Identifiers
- Primary DI / UDI-DI
- D800CPAD01010 FDA UDI
- FDA Product Code
- EBI FDA UDI
- GMDN Term
- Dental prosthesis-component adhesive FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3760 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
Yes
FDA UDI
Category: Dental prosthesis-component adhesive
Polibond 30 ml by Zirkonzahn 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
- 3Delta Denture Fix — DeltaMed GmbH · Class II
- PRO Resins Denture Fix — DeltaMed GmbH · Class II
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
- Zirkonzahn GmbH
Sources (1)
- FDA UDI 94c25318-f35b-4234-9ce6-b5e029b6e250 34 fields · synced May 31, 2026