Identity
- Trade Name
- Porcelain Bonding Resin FDA UDI
- Generic Name
- Dental prosthesis priming agent FDA UDI
- Device Name
- Porcelain Bonding Resin 6ml Bottle FDA UDI
- Model / Reference
- B-3110 FDA UDI
- Description
- Porcelain Bonding Resin 6ml Bottle FDA UDI
Identifiers
- Catalog Number
- B-3110 FDA UDI
- Primary DI / UDI-DI
- 00810111542432 FDA UDI
- FDA Product Code
- EBF FDA UDI
- GMDN Term
- Dental prosthesis priming agent FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3690 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
No
FDA UDI
Category: Dental prosthesis priming agent
Porcelain Bonding Resin by Bisco Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental prosthesis priming agent.
- ACRIFIX — DeltaMed GmbH · Class II
- HC PRIMER — SHOFU DENTAL CORP. · Class II
- CLEARFIL™ CERAMIC PRIMER PLUS — KURARAY NORITAKE DENTAL INC. · Class II
- Best Etch — Vista Dental · Class II
- Mirage Silane Bond Enhancer — Chameleon Dental Products, Inc.
- 3Delta Denture Bond — DeltaMed GmbH · Class II
- CLEARFIL™ PORCELAIN BOND ACTIVATOR — KURARAY NORITAKE DENTAL INC. · Class II
- CLEARFIL™ CERAMIC PRIMER PLUS — KURARAY NORITAKE DENTAL INC. · 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 |
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Manufacturer
- Manufacturer
- Bisco Inc.
Sources (1)
- FDA UDI 88e8d84a-09de-4d5b-bb03-6840953b1c51 36 fields · synced May 30, 2026