Clearfil Universal Bond Quick 2
CLEARFIL Universal Bond Quick 2 BOND is a light cure dental adhesive for treating dentin, enamel and prosthetic materials in direct and indirect restorations. Uses include composite…
CLEARFIL Universal Bond Quick 2 BOND is a light cure dental adhesive for treating dentin, enamel and prosthetic materials in direct and indirect restorations. Uses include composite restorations, cavity or abutment sealing, intraoral repairs, post cementation and core buildups.
The adhesive can be used in a self etch approach or with the associated K-ETCHANT gel for selective enamel etching or total etching. The etchant contains 35% phosphoric acid in an aqueous gel with colloidal silica.
Curing Combinations
CLEARFIL DC Activator enables a dual curing mechanism when required for the selected restorative combination. It is not required with CLEARFIL DC CORE PLUS, the specified Kuraray self adhesive resin cements or PANAVIA Veneer LC. The bonding system is also indicated for exposed root surfaces and hypersensitive teeth.
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) | K231039 |
| Record published | 2024-02-27 |
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 |
|---|---|---|---|
| #4044-KA | In distribution | ||
| #4041-KA | In distribution | ||
| #4047-KA | In distribution | ||
| #4048-KA | 5 | In distribution | |
| #4042-KA | In distribution | ||
| #4045-KA | In distribution | ||
| #4046-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.