Identity
- Trade Name
- Ca-Lok - Calcium Base / Liner FDA UDI
- Generic Name
- Dental composite resin FDA UDI
- Device Name
- Ca-Lok™ is a light-cured, calcium-filled resin with adhesive properties to dentin and seamless compatibility to other restorative materials. Ca-Lok™ is radiopaque and releases fluoride. Ca-Lok™ is used as a protective liner with adhesion, which can be placed under restorative materials and cements for many types of cavity preparations. With its flowable viscosity and unique handling characteristics, precise placement and control is achieved. FDA UDI
- Model / Reference
- Kit - 1.8 gm Syr 2 pk FDA UDI
- Description
- Ca-Lok™ is a light-cured, calcium-filled resin with adhesive properties to dentin and seamless compatibility to other restorative materials. Ca-Lok™ is radiopaque and releases fluoride. Ca-Lok™ is used as a protective liner with adhesion, which can be placed under restorative materials and cements for many types of cavity preparations. With its flowable viscosity and unique handling characteristics, precise placement and control is achieved. FDA UDI
Identifiers
- Catalog Number
- 05-7000 FDA UDI
- Primary DI / UDI-DI
- D8370570000 FDA UDI
- FDA Product Code
- EBF FDA UDI
- GMDN Term
- Dental composite resin FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3690 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
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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
Dimensions & Sizes
- Size
- Weight — 1.8 Gram FDA UDI
Category: Dental composite resin
Ca-Lok - Calcium Base / Liner by Taub Products — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Dental composite resin.
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- Llis — Dentscare Ltda · Class II
- Capo Universal, 6 g — Schütz Dental GmbH · Class II
- OMNICHROMA — TOKUYAMA DENTAL CORPORATION · 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
- Taub Products
Sources (1)
- FDA UDI fda0b041-5168-4be5-9b1d-285b8f7aae5c 37 fields · synced Jun 8, 2026