Identity
- Trade Name
- CLEARFIL™ CERAMIC PRIMER PLUS FDA UDI
- Generic Name
- Dental prosthesis priming agent FDA UDI
- Device Name
- Trial FDA UDI
- Model / Reference
- #3638-KA FDA UDI
- Description
- Trial FDA UDI
Identifiers
- Primary DI / UDI-DI
- EKUR003638KA1 FDA UDI
- 510(k) Number
- K150703 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
Clearfil™ Ceramic Primer Plus by Kuraray Noritake Dental 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
- Best Etch — Vista Dental · Class II
- Mirage Silane Bond Enhancer — Chameleon Dental Products, Inc.
- 3Delta Denture Bond — DeltaMed GmbH · Class II
- Vista Zirconia Primer 4ml Bottle — Vista Dental · Class II
- Porcelain Primer — BISCO INC. · Class II
- Porcelain Etch — Vista Dental · Class II
Cleared under the same submission
K150703 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Kuraray Noritake Dental Inc.
Sources (1)
- FDA UDI 36b27834-fbd9-4616-b038-d52b41aa26bf 34 fields · synced Jun 1, 2026