Light Cure Dental Adhesive
Light Cure Dental Adhesive bonds dental restorative materials to tooth structure. It supports direct bonding beneath light-cured composite, compomer and resin-modified glass-ionomer…
Light Cure Dental Adhesive bonds dental restorative materials to tooth structure. It supports direct bonding beneath light-cured composite, compomer and resin-modified glass-ionomer restorations, as well as repair of ceramic, composite and metal-alloy restorations. It is intended for prescription use.
The single-component adhesive contains unfilled multifunctional methacrylate resin in an ethanol-based solvent. Visible light initiates curing. It can be used with self-etch, total-etch or selective enamel-etch procedures according to the chosen restorative workflow.
Indirect Restorations
Used with resin cement, the adhesive supports cementation of crowns, bridges, inlays, onlays, veneers, posts and other indirect restorations. Compatible restoration material categories include metal alloys, metal-ceramic, all-ceramic, porcelain, composites and their combinations.
Who Else Makes It
Concentrated in Jilin (2), Liaoning (1), Guangdong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Liaoning Upcera Co., Ltd. | Benxi | Liaoning | Contract manufacturer | 10 |
| Shenzhen Upcera Digital Dental Technology Co., Ltd. | Shenzhen | Guangdong | Exporter | 10 |
| Rizhao Huge Biomaterials Company, Ltd. | Rizhao | Shandong | Manufacturer | 7 |
| CAO (China) Medical Equipment Company, Limited | Langfang | Hebei | Contract manufacturer | 6 |
| Sincera Technology (Changchun) Co., Ltd. | Changchun | Jilin | Manufacturer | 2 |
| Sino-Dentex Co., Ltd. | Changchun | Jilin | Manufacturer | 2 |
Record
| Listed by | Rizhao Huge Biomaterials Company, Ltd., China |
|---|---|
| FDA product code | KLE |
| Device type | Agent, Tooth Bonding, Resin |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3200 |
| Establishment | Manufacturer |
| 510(k) | K201787 |
| Record published | 2021-12-15 |
| Record revised | 2024-02-16 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| / | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Epic® | Parkell, Inc. | 22 |
| All-Bond Universal | Bisco, Inc. | 18 |
| Henry Schein | Henry Schein, Inc. | 16 |
| Peak Universal Bond | Ultradent Products Inc. | 16 |
| Brush&Bond® | Parkell, Inc. | 16 |
| All-Bond 2 | Bisco, Inc. | 15 |
| The Orthodontic Store | Young Innovations Inc. | 15 |
| All-Bond 3 | Bisco, Inc. | 13 |
| Scotchbond™ Universal | 3M Deutschland GmbH | 13 |
| Select HV Etch w/BAC | Bisco, Inc. | 12 |
| Prelude | Danville Materials, LLC | 12 |
| Jade | Dharma Research, Inc. | 12 |
Showing 12 of 609. All products under Agent, Tooth Bonding, Resin
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K242530 | 2024-12-20 |
| K242749 | 2024-11-08 |
| K221450 | 2022-09-12 |
| K201787 | 2020-09-25 |
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.