Cal LC
CAL-LC is a light-cured dental material used as a cavity liner and for pulp capping. It is a highly filled, self-adhering paste supplied in a syringe with applicator tips. The formulation…
CAL-LC is a light-cured dental material used as a cavity liner and for pulp capping. It is a highly filled, self-adhering paste supplied in a syringe with applicator tips.
The formulation combines a methacrylate resin with calcium hydroxide, barium sulfate, glass filler and silica. Photoinitiators allow the paste to harden with light, forming the placed lining or capping material.
Material Role
As a liner, CAL-LC forms a layer within a prepared cavity; pulp capping is its other specified use. Its single syringe presentation differs from the separate base-and-catalyst paste system used by CalUltra, another material in the manufacturer’s range.
Who Else Makes It
Registered in Guangxi.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Guilin Kevin Peter Technology Co., Ltd. | Guilin | Guangxi | Manufacturer | 13 |
Record
| Listed by | Prevest Denpro Limited, India |
|---|---|
| FDA product code | EJK |
| Device type | Liner, Cavity, Calcium Hydroxide |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3250 |
| Establishment | Manufacturer |
| 510(k) | K212475 |
| Record published | 2022-12-08 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Trial Pack | In distribution | |
| Intro Pack | In distribution | |
| Economy Pack | In distribution | |
| Economy Pack | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Roeko Calcium Hydroxide Plus Points | Coltène/Whaledent AG | 15 |
| Hygenic | Coltene/Whaledent Gmbh & Co. KG | 14 |
| Calcigel | Prevest Denpro Limited | 8 |
| TheraCal LC | Bisco, Inc. | 8 |
| Hydroxyline | Taub Products | 8 |
| GC Fuji Lining™ | GC America Inc. | 7 |
| TheraCal PT | Bisco, Inc. | 6 |
| Super Seal | Phoenix Dental, Inc. | 5 |
| AxioCAL LC | Axiodent Inc. | 4 |
| Ultra-Blend Plus | Ultradent Products Inc. | 4 |
| AxioCAL | Axiodent Inc. | 4 |
| UltraCal XS | Ultradent Products Inc. | 4 |
Showing 12 of 84. All products under Liner, Cavity, Calcium Hydroxide
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K212475 | 2022-05-13 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.