Hydrofluoric Acid Etching Gel
Hydrofluoric Acid Etching Gel conditions porcelain and ceramic restorations before they are bonded or cemented. It is intended for use outside the mouth on restorations such as veneers,…
Hydrofluoric Acid Etching Gel conditions porcelain and ceramic restorations before they are bonded or cemented. It is intended for use outside the mouth on restorations such as veneers, crowns and inlays, rather than direct treatment of teeth or oral tissue.
The water-based gel contains hydrofluoric acid, a thickening agent and pigment. It comes in a syringe and is applied to the restoration surface through a disposable dispensing tip. Its red colour provides contrast on the treated surface.
Material Form
The gel is soluble and miscible in water. Its role is surface conditioning before bonding, with the restoration remaining outside the patient during etching.
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 | Rizhao Huge Biomaterials Company, Ltd., China |
|---|---|
| FDA product code | KLE |
| Device type | Agent, Tooth Bonding, Resin |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3200 |
| Establishment | Manufacturer |
| 510(k) | K242530 |
| Record published | 2025-10-27 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| E9 | In distribution | |
| W-VSM-HF-Etchant-E9 | 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 |
|---|---|
| K242530 | 2024-12-20 |
| K242749 | 2024-11-08 |
| K221450 | 2022-09-12 |
| K201787 | 2020-09-25 |
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.