K-Etchant Syringe
The K-ETCHANT syringe needle tip is a dispensing accessory for applying etching gel to a tooth surface. It attaches to the syringe outlet so the clinician can direct the gel during enamel…
The K-ETCHANT syringe needle tip is a dispensing accessory for applying etching gel to a tooth surface. It attaches to the syringe outlet so the clinician can direct the gel during enamel or dentin etching and cleaning of restorative materials.
The dispensing nozzle is made from polypropylene and stainless steel. It carries the material from the syringe to the selected application site; the etching chemistry belongs to the gel rather than the tip.
Listed Item
Needle tips (E)
Associated Etchant
The K-ETCHANT gel contains 35% phosphoric acid in an aqueous mixture with colloidal silica. Its flowable consistency supports selective placement through the nozzle. The syringe body uses polypropylene and polyethylene.
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 | Kuraray Noritake Dental, Inc., United States |
|---|---|
| FDA product code | KLE |
| Device type | Agent, Tooth Bonding, Resin |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3200 |
| 510(k) | K133078 |
| Record published | 2017-02-17 |
| Record revised | 2025-10-09 (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 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| #3252-KA | 2 | In distribution | |
| #3253-KA | 20 | 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 |
|---|---|
| K231039 | 2023-12-13 |
| K161042 | 2016-10-25 |
| K150703 | 2015-08-13 |
| K133078 | 2013-12-20 |
| K132450 | 2013-11-01 |
| K131430 | 2013-08-30 |
| K131432 | 2013-08-22 |
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.