Henry Schein
A fast-acting desensitizer which can be used with total etch and selective etch adhesive systems. Additional treats sensitivity resulting from exposed dentin.
6manufacturers in China registered for this device type
16catalogue numbers in this listing
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 | Henry Schein, Inc., United States |
|---|---|
| FDA product code | KLE |
| Device type | Agent, Tooth Bonding, Resin |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3200 |
| Record published | 2016-09-24 |
| Record revised | 2024-02-16 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 2 to 10 °C; Storage environment temperature 35 to 50 °F; Special storage condition: Keep out of sun |
| Sizes | Total volume 0.125 to 10 ml; weight 0.35 to 60 g; needle gauge 22 G |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 1126719 | Total Volume 0.125 ml | In distribution | |
| 5700603 | In distribution | ||
| 9004429 | Total Volume 5 ml | In distribution | |
| 1025823 | Needle Gauge 22 G | In distribution | |
| 9001002 | Weight 9 g | In distribution | |
| 1065167 | Total Volume 9 ml | In distribution | |
| 1010711 | Syringe Tip x 20 | In distribution | |
| 5700604 | 50 | In distribution | |
| 1004649 | Syringe x 4 | In distribution | |
| 1126966 | Single Use Predosed Tips x 50 | In distribution | |
| 1016815 | Syringe Tip x 20 | In distribution | |
| 1015396 | Syringe x 12 | In distribution | |
| 5702794 | Bottle | In distribution | |
| 1026893 | Weight 60 g | In distribution | |
| 1024668 | Total Volume 5 ml | In distribution | |
| 1024190 | 5 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Epic® | Parkell, Inc. | 22 |
| All-Bond Universal | Bisco, Inc. | 18 |
| 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 |
| Bisfil 2B | Bisco, Inc. | 12 |
Showing 12 of 609. All products under Agent, Tooth Bonding, Resin
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.