G-Premio™ Bond
G-Premio Bond is a one-component, light-cured dental adhesive for bonding compatible composites to tooth structure and for specified intraoral repair procedures. It is supplied as liquid in…
G-Premio Bond is a one-component, light-cured dental adhesive for bonding compatible composites to tooth structure and for specified intraoral repair procedures. It is supplied as liquid in a 5 mL bottle or unit dose.
The adhesive forms chemical and mechanical bonds through polymerization of methacrylate ester monomers. Compatible bonding surfaces include tooth structure, composites, hybrid ceramics, ceramics and metals.
Listed Item
G-Premio™ BOND 5mL Kit: 1 bottle 5mL, 50 disposable applicators, 20 disposable trays
Applications and Curing
Uses include bonding light-cured composites or compomers, repair of specified ceramic or metal-backed restorations, and treatment of hypersensitive teeth. Dual-cure luting or core build-up composites may be bonded only when those materials are also light-cured.
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 | GC America Inc., United States |
|---|---|
| FDA product code | KLE |
| Device type | Agent, Tooth Bonding, Resin |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3200 |
| Establishment | Contract manufacturer, Remanufacturer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K143140 |
| Record published | 2019-02-01 |
| Record revised | 2025-03-17 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 4 to 25 °C; Storage environment temperature 39 to 77 °F |
| Packaging | Carton of 42 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 012691 | In distribution | ||
| 012696 | In distribution | ||
| 009277 | In distribution | ||
| 012696 | In distribution | ||
| 009276 | 50 | In distribution | |
| 012691 | In distribution | ||
| 009276 | 50 | In distribution | |
| 009552 | In distribution | ||
| 009552 | In distribution | ||
| 009275 | 50 | 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 |
|---|---|
| K251124 | 2025-10-02 |
| K200682 | 2020-10-02 |
| K180917 | 2018-11-20 |
| K143140 | 2015-04-20 |
| K082768 | 2008-10-21 |
| K041471 | 2004-06-29 |
| K013997 | 2002-02-20 |
| K981514 | 1998-06-16 |
| K972594 | 1997-08-26 |
| K953166 | 1995-09-27 |
| K935961 | 1994-03-10 |
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.