Orthosource
Blue Etch 1.2 cc syringe
1manufacturer
20catalogue numbers in this listing
Who Else Makes It
Registered in Shandong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Rizhao Huge Biomaterials Company, Ltd. | Rizhao | Shandong | Manufacturer | 7 |
Record
| Listed by | Orthosource, Inc., United States |
|---|---|
| FDA product code | EBC |
| Device type | Sealant, Pit And Fissure, And Conditioner |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3765 |
| 510(k) | K861245 |
| Record published | 2019-11-12 |
| Record revised | 2025-10-09 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, expiry date |
| Packaging | 4 syr kit of 4, syr with tips kit, 5 syr kit w tips of 5, 50 syr kit of 50, 20 syr kit of 20 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 557-619 | In distribution | |
| 557-519 | In distribution | |
| 557-422 | In distribution | |
| 567-041 | In distribution | |
| 557-412 | In distribution | |
| 557-617 | In distribution | |
| 557-467 | In distribution | |
| 557-515 | In distribution | |
| 557-418-C | In distribution | |
| 557-468 | In distribution | |
| 557-419 | In distribution | |
| 557-466 | In distribution | |
| 557-415 | In distribution | |
| 557-615 | In distribution | |
| 557-617-C | In distribution | |
| 557-618 | In distribution | |
| 557-424 | In distribution | |
| 567-040 | In distribution | |
| 557-418 | In distribution | |
| 557-618-C | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| UltraSeal XT | Ultradent Products Inc. | 22 |
| SciPharm Pit & Fissure Sealer Bonding Agent | Scientific Pharmaceuticals, Inc. | 20 |
| Visalys Fill | Kettenbach Gmbh & Co KG | 14 |
| Riva Protect | SDI Ltd. | 14 |
| Venus Diamond Flow | Kulzer SRL | 9 |
| Conseal | SDI Ltd. | 9 |
| Delton® | Dentsply Professional | 9 |
| Helioseal Clear F F Plus | Ivoclar Vivadent Aktiengesellschaft | 8 |
| Patterson® | Patterson Dental Supply, Inc. | 8 |
| Clinpro™ | 3M Company | 7 |
| Visalys Flow | Kettenbach Gmbh & Co KG | 7 |
| Enamel Coating Resin | Rizhao Huge Biomaterials Company, Ltd. | 6 |
Showing 12 of 133. All products under Sealant, Pit And Fissure, And Conditioner
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.