Identity
- Trade Name
- Glidewell Zirconia Primer FDA UDI
- Generic Name
- Dental prosthesis priming agent FDA UDI
- Device Name
- Glidewell Zirconia Primer 2X0.1ml FDA UDI
- Model / Reference
- 70-1198-PVC0004 FDA UDI
- Description
- Glidewell Zirconia Primer 2X0.1ml FDA UDI
Identifiers
- Catalog Number
- 70-1198-PVC00040 FDA UDI
- Primary DI / UDI-DI
- D745701198PVC00041 FDA UDI
- 510(k) Number
- K221033 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
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 priming agent
Glidewell Zirconia Primer by Prismatik Dentalcraft, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental prosthesis priming agent.
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- CLEARFIL™ CERAMIC PRIMER PLUS — KURARAY NORITAKE DENTAL INC. · Class II
Cleared under the same submission
K221033 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
- Prismatik Dentalcraft, Inc.
Sources (1)
- FDA UDI e61bae3a-468f-4dd9-9686-14b811048bef 36 fields · synced May 29, 2026