Tokuyama Universal Bond II
Tokuyama Universal Bond II is a two-component, self-curing dental adhesive for direct and indirect restorations. Mixing Bond A and Bond B starts polymerization; applying the mixture as a…
Tokuyama Universal Bond II is a two-component, self-curing dental adhesive for direct and indirect restorations. Mixing Bond A and Bond B starts polymerization; applying the mixture as a thin layer and air-drying concentrates it to form the adhesive layer.
The system is compatible with light-cured, self-cured and dual-cured composite materials and can be used with self-etch, selective-enamel-etch or total-etch techniques. Its uses include restoration bonding, intraoral repair, resin-cement attachment and bonding core build-ups.
Listed Item
Sample Kit
Components and Supply
Bond A and Bond B are packaged separately in plastic bottles to keep the reactive components apart during storage. The adhesive contains methacrylate monomers, solvents, a silane coupling agent and a chemical catalyst system, and is supplied nonsterile.
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 | Tokuyama Dental Corporation, United States |
|---|---|
| FDA product code | KLE |
| Device type | Agent, Tooth Bonding, Resin |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3200 |
| 510(k) | K203760 |
| Record published | 2021-06-30 |
| Record revised | 2024-02-16 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 0 to 25 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 15329 | In distribution | |
| 15320 | In distribution | |
| 15310 | In distribution | |
| 15315 | 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 |
|---|---|
| K203760 | 2021-05-25 |
| K171226 | 2017-11-28 |
| K070215 | 2007-03-30 |
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.