Identity
- Trade Name
- Z-Prime Plus FDA UDI
- Generic Name
- Dental prosthesis priming agent FDA UDI
- Device Name
- Z-Prime Plus 0.5ml BTL SMPL FDA UDI
- Model / Reference
- B-6003S FDA UDI
- Description
- Z-Prime Plus 0.5ml BTL SMPL FDA UDI
Identifiers
- Catalog Number
- B-6003S FDA UDI
- Primary DI / UDI-DI
- 00810111540070 FDA UDI
- 510(k) Number
- K091705 FDA UDI
- FDA Product Code
- KLE FDA UDI
- GMDN Term
- Dental prosthesis priming agent FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3200 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
Z-Prime Plus 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
Cleared under the same submission
K091705 also covers:
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 9121529f-f63c-4b76-9c24-576097270d1a 37 fields · synced May 30, 2026