EZ Bond Universal (EZB50)
EZ Bond Universal is a dental adhesive that joins restorative resin materials to tooth surfaces. It combines the conditioning, priming and bonding functions in one bottled formulation. A…
EZ Bond Universal is a dental adhesive that joins restorative resin materials to tooth surfaces. It combines the conditioning, priming and bonding functions in one bottled formulation. A thin adhesive layer is applied to the surface being restored to support bonding with polymerizable resin.
The adhesive is used with light cured composite or compomer fillings and for repairs to existing restorations. Its listed repair uses include composite, porcelain fused to metal and ceramic restorations without an additional primer. It can also serve as a protective varnish over glass ionomer fillings.
Listed Item
EZ Bond Universal is dentin adhesion system that functions as a conditioner, primer and adhesive resin in a single component. EZB50 (5.0g)
Etching Approaches
Depending on the restoration, the adhesive can be used with self etching, total etching or selective etching procedures. Its formulation includes a phosphate monomer, HEMA and ethanol.
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 | 2023-04-12 |
| Record revised | 2024-06-14 (version 4) |
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 |
|---|---|---|
| 6012 | 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.