Opaquer
Opaquer Catalyst 3ml Bottle Pkg
1manufacturer
6catalogue numbers in this listing
3510(k) clearances naming this product code
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 | Bisco, Inc., United States |
|---|---|
| FDA product code | EBC |
| Device type | Sealant, Pit And Fissure, And Conditioner |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3765 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K874557 |
| Record published | 2022-10-11 |
| Record revised | 2024-02-16 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Storage environment temperature 20 to 25 °C |
| Packaging | Item no: b-2112q, item no: b-2122q |
| Distribution end date | 2022-11-03 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| B-2112 | In distribution | |
| B-2122 | In distribution | |
| B-2122Q | Withdrawn | |
| B-2122 | Withdrawn | |
| B-2112 | Withdrawn | |
| B-2112Q | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| UltraSeal XT | Ultradent Products Inc. | 22 |
| SciPharm Pit & Fissure Sealer Bonding Agent | Scientific Pharmaceuticals, Inc. | 20 |
| Orthosource | Orthosource, 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 |
Showing 12 of 133. All products under Sealant, Pit And Fissure, And Conditioner
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K162598 | 2017-05-23 |
| K874557 | 1988-01-28 |
| K874556 | 1988-01-28 |
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.