Lightpaint on Surface
Lightpaint on Surface is a dental sealing lacquer for the final coating of resin temporaries. Applied to a restoration outside the mouth, it forms a smooth, shiny surface. It is intended…
Lightpaint on Surface is a dental sealing lacquer for the final coating of resin temporaries. Applied to a restoration outside the mouth, it forms a smooth, shiny surface. It is intended for prescription use by healthcare professionals.
The single-component lacquer contains multifunctional acrylates and photoinitiators. Exposure to a dental light-curing unit initiates a free-radical addition reaction, polymerizing the resin coating on the restoration.
Presentation and Application
The lacquer is supplied in glass bottles. Its stated coating applications include resin parts of complete or partial dental prostheses and provisional crowns and bridges. The material is applied before curing with the dental light source.
Who Else Makes It
Registered in Jiangsu.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Yamahachi Dental Material (Changshu) Co., Ltd. | Changshu | Jiangsu | Manufacturer | 9 |
Record
| Listed by | Dreve Dentamid Gmbh, Germany |
|---|---|
| FDA product code | EBD |
| Device type | Coating, Filling Material, Resin |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3310 |
| Establishment | Contract manufacturer, Manufacturer |
| 510(k) | K162408 |
| Record published | 2018-04-12 |
| Record revised | 2022-08-11 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 18 to 28 °C |
| Distribution end date | 2021-08-10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| D38239 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| ID Lightcure System | ID Korea Co., Ltd. | 63 |
| Minute Stain | Taub Products | 56 |
| Optiglaze™ | GC America Inc. | 44 |
| Rodin | PAC-Dent Inc. | 39 |
| Renamel® Flowable Microfill | Deltamed Gmbh | 27 |
| Vita Akzent® LC | Vita – Zahnfabrik H. Rauter Gesellschaft mit beschränkter Haftung & Co Kommanditgesellschaft | 27 |
| Renamel® Flowable Microfill | Cosmedent, Inc. | 26 |
| Radica® | Dentsply LLC | 20 |
| SciPharm Support Self Cured Core Build-Up Restorative Reverse | Scientific Pharmaceuticals, Inc. | 18 |
| Renamel® Flowable Microhybrid | Cosmedent, Inc. | 16 |
| Glaze | Taub Products | 14 |
| Signum matrix | Kulzer SRL | 14 |
Showing 12 of 100. All products under Coating, Filling Material, Resin
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K162408 | 2018-04-05 |
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.