ApaCal ART
ApaCal ART is a dental paste used as a cavity liner before placement of restorative material. It is also intended for direct or indirect pulp capping and management of deep caries lesions.…
ApaCal ART is a dental paste used as a cavity liner before placement of restorative material. It is also intended for direct or indirect pulp capping and management of deep caries lesions.
The single component paste is dispensed from a prefilled syringe through an applicator tip and hardened with light. Tricalcium phosphate and hydroxyapatite reinforce the material, which contains a resin matrix and inorganic fillers.
Composition
The formulation includes urethane dimethacrylate, triethylene glycol dimethacrylate, barium sulfate, silanated barium glass and fumed silica, together with calcium hydroxide, photoinitiators and stabilizers. The paste is supplied nonsterile and has a three year shelf life.
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 | 2022-12-06 |
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 |
|---|---|---|
| Intro Pack | In distribution | |
| Trial Pack | In distribution | |
| Trial 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 |
| Cal LC | Prevest Denpro Limited | 4 |
| AxioCAL LC | Axiodent Inc. | 4 |
| Ultra-Blend Plus | Ultradent Products Inc. | 4 |
| AxioCAL | Axiodent 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.