Jade
Jade Blue 37% Phosphoric Acid Etchant Gel - 1 x 50ml Syringe, 50 Pre-bent 23ga Tips, 4 x 1.2ml Empty Syringes & Instruction Insert Instruction Insert
6manufacturers in China registered for this device type
12catalogue numbers in this listing
1510(k) clearance
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 | Dharma Research, Inc., United States |
|---|---|
| FDA product code | KLE |
| Device type | Agent, Tooth Bonding, Resin |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3200 |
| 510(k) | K150696 |
| Record published | 2016-10-07 |
| Record revised | 2025-10-09 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Storage environment temperature 10 to 25 °C |
| Packaging | Case of 48, case of 25, case of 30 |
| Sizes | Total volume 1.2 to 50 ml |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 20-00016 | Total Volume 50 ml | In distribution | |
| 20-00005 | Total Volume 50 ml | In distribution | |
| 20-00091 | Total Volume 50 ml | In distribution | |
| 20-00006 | Total Volume 10 ml | In distribution | |
| 20-00008 | Total Volume 1.2 ml | 4 | In distribution |
| 20-00003 | Total Volume 1.2 ml | 4 | In distribution |
| 20-00010 | Total Volume 50 ml | In distribution | |
| 20-00002 | Total Volume 10 ml | In distribution | |
| 20-00007 | Total Volume 10 ml | In distribution | |
| 20-00009 | Total Volume 1.2 ml | 25 | In distribution |
| 20-00004 | Total Volume 1.2 ml | 25 | In distribution |
| 20-00001 | Total Volume 10 ml | 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 |
| Bisfil 2B | Bisco, Inc. | 12 |
Showing 12 of 609. All products under Agent, Tooth Bonding, Resin
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K150696 | 2015-06-23 |
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.