Els Unibond
els unibond is a dental adhesive that bonds light cured restorative materials to enamel and dentin. Its uses include direct composite restorations and fixation of indirect restorations with…
els unibond is a dental adhesive that bonds light cured restorative materials to enamel and dentin. Its uses include direct composite restorations and fixation of indirect restorations with light curing composite cements. It combines the adhesive steps in a single self etching component.
The resin based liquid is applied as a bonding layer and hardened by light curing. Its formulation contains monomers, film formers, fillers, solvents, initiators, silanization agents and stabilizers. The cured material forms the adhesive interface between tooth structure and the restorative material.
Listed Item
Light-curing, 1-component self-etching adhesive to create a permanent marginal-gap-free adhesion between the tooth structure (dentine, enamel) and the light-curing filling/ fixing material.
Indirect Restorations
The stated indirect applications include inlays, onlays, crowns and bridges when fixed with light curing composite cement. The adhesive is supplied in a bottle as a nonsterile prescription product.
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 | Saremco Dental AG, Switzerland |
|---|---|
| FDA product code | KLE |
| Device type | Agent, Tooth Bonding, Resin |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3200 |
| Establishment | Complaint-file establishment, Manufacturer |
| 510(k) | K252151 |
| Record published | 2026-04-28 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 4 to 28 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| / | 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 |
|---|---|
| K252151 | 2025-12-05 |
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.