Hi-Bond Universal
Hi-Bond Universal is a light-curing dental adhesive for direct and indirect restorations. Its single-component formulation combines etching, priming and bonding and supports self-etch or…
Hi-Bond Universal is a light-curing dental adhesive for direct and indirect restorations. Its single-component formulation combines etching, priming and bonding and supports self-etch or total-etch approaches.
The liquid contains resin monomers, inorganic fillers, initiators, accelerators, ethanol and antioxidants. It is supplied in a polyethylene and polypropylene bottle for application to the restorative interface.
Listed Item
Hi-Bond Universal is a light-curing dentin adhesive system. (5ml)
Additional Uses
Indications include intraoral repair of fixed restorations containing ceramics, metals or composites, sealing hypersensitive tooth structure, protective varnishing of glass-ionomer fillings and enamel priming for orthodontic use.
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 | Mediclus Co., Ltd., South Korea |
|---|---|
| FDA product code | KLE |
| Device type | Agent, Tooth Bonding, Resin |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3200 |
| Establishment | Manufacturer |
| 510(k) | K230465 |
| Record published | 2026-06-01 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Storage environment temperature 1 to 25 °C |
| Sizes | Total volume 5 ml |
| Distribution end date | 2026-06-01 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 303-2 | Total Volume 5 ml | Withdrawn |
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 |
|---|---|
| K260485 | 2026-05-14 |
| K230465 | 2023-05-22 |
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.