EZ Bond Universal (EZB15)
EZ Bond Universal is a single-bottle dental adhesive used to bond restorative materials to tooth surfaces. It supports direct composite restorations and repair of existing restorations. The…
EZ Bond Universal is a single-bottle dental adhesive used to bond restorative materials to tooth surfaces. It supports direct composite restorations and repair of existing restorations.
The adhesive can be used with self-etch, total-etch or selective-etch techniques according to the procedure. It bonds methacrylate-based restorative materials to enamel and dentin and can be used on specified indirect restorative substrates without an additional primer step.
Listed Item
EZ Bond Universal is dentin adhesion system that functions as a conditioner, primer and adhesive resin in a single component. EZB15 (1.5g)
Restoration Uses
Applications include light-cured composite or compomer fillings, repair of composite restorations and intraoral repair of porcelain-fused-to-metal or ceramic restorations. It can also serve as a protective varnish for glass ionomer fillings. The listed EZB15 presentation contains 1.5 g of adhesive.
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 | Meta Biomed Co., Ltd., South Korea |
|---|---|
| FDA product code | KLE |
| Device type | Agent, Tooth Bonding, Resin |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3200 |
| Establishment | Repacker / relabeller, Private-label distributor, Manufacturer |
| 510(k) | K230009 |
| Record published | 2024-06-13 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 6008 | 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 |
|---|---|
| K230009 | 2023-03-03 |
| K180802 | 2018-08-29 |
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.