Clearfil™ SE Bond 2
Clearfil SE Bond 2 is a two-component self-etching dental bonding agent for direct and indirect restorations. Its primer treats dentin and enamel together, followed by application of the…
Clearfil SE Bond 2 is a two-component self-etching dental bonding agent for direct and indirect restorations. Its primer treats dentin and enamel together, followed by application of the light-cured bond.
Mixing the bond with Clearfil DC Activator provides a dual-cure mechanism for use with dual-cure or self-cure filling materials, cements and core materials. The curing arrangement therefore depends on the accompanying restorative system.
Restorative Applications
Indications include composite restorations, cavity sealing, exposed-root or hypersensitivity treatment, intraoral repairs, post cementation and core buildup. It also supports cementation of inlays, onlays, crowns, bridges and veneers with composite resin cement.
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 | Kuraray Noritake Dental, Inc., United States |
|---|---|
| FDA product code | KLE |
| Device type | Agent, Tooth Bonding, Resin |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3200 |
| 510(k) | K131432 |
| Record published | 2017-02-17 |
| Record revised | 2024-02-16 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| #3286-KA | 50 | In distribution | |
| #3272-KA | 3 | In distribution | |
| #3281-KA | 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 |
|---|---|
| K231039 | 2023-12-13 |
| K161042 | 2016-10-25 |
| K150703 | 2015-08-13 |
| K133078 | 2013-12-20 |
| K132450 | 2013-11-01 |
| K131430 | 2013-08-30 |
| K131432 | 2013-08-22 |
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.