Identity
- Trade Name
- Cavitec FDA UDI
- Generic Name
- Dental cavity liner FDA UDI
- Device Name
- Cavity Liner FDA UDI
- Model / Reference
- 00604 FDA UDI
- Description
- Cavity Liner FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00841396102028 FDA UDI
- FDA Product Code
- EJK FDA UDI
- GMDN Term
- Dental cavity liner FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3250 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Weight — 26 Gram FDA UDI
Category: Dental cavity liner
Cavitec by Kerr Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental cavity liner.
- Hygenic — Coltene/Whaledent Inc. · Class II
- LINING CEMENT — Gc America Inc. · Class II
- GC Fuji LINING™ — Gc America Inc. · Class II
- Hygenic — Coltene/Whaledent Inc. · Class II
- Hygenic — Coltene/Whaledent Inc. · Class II
- Hygenic — Coltene/Whaledent Inc. · Class II
- LINING CEMENT — Gc America Inc. · Class II
- Hygenic — Coltene/Whaledent 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
- Kerr Corporation
Sources (1)
- FDA UDI 556eb190-f34c-46d2-929a-fad351febc1b 36 fields · synced Jun 8, 2026