Identity
- Trade Name
- K-Primer FDA UDI
- Generic Name
- Dental repair kit, ceramic FDA UDI
- Device Name
- K-Primer ceramic primer, bonding agent, composite bonding 3 ml dropper bottle FDA UDI
- Model / Reference
- APK25003 FDA UDI
- Description
- K-Primer ceramic primer, bonding agent, composite bonding 3 ml dropper bottle FDA UDI
Identifiers
- Catalog Number
- APK25003 FDA UDI
- Primary DI / UDI-DI
- EBREAPK250030 FDA UDI
- FDA Product Code
- EBI FDA UDI
- GMDN Term
- Dental repair kit, ceramic 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
No
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 repair kit, ceramic
K-Primer by bredent GmbH & Co. KG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental repair kit, ceramic.
- Interface A Bottle — Vista Dental · Class II
- EMBRACE WETBOND RESTORATION & PFM REPAIR KIT — Pulpdent Corporation · Class II
- ReVeneer Adhesive Set — Schütz Dental GmbH · Class II
- GC CERAMIC PRIMER II — Gc America Inc. · Class II
- FUSION Silane — Taub Products · Class II
- ReVeneer Composite Filli — Schütz Dental GmbH · Class II
- EtchArrest — ULTRADENT PRODUCTS, INC. · Class II
- Etching Gel Kit — Cosmedent, Inc.
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
- bredent GmbH & Co. KG
Sources (1)
- FDA UDI b971b8cc-f889-43d9-b06d-8d1d5cf39628 35 fields · synced Jun 8, 2026