Conseal
Conseal F SYR Bulk KT
1manufacturer
9catalogue 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 | SDI Ltd., Australia |
|---|---|
| FDA product code | EBC |
| Device type | Sealant, Pit And Fissure, And Conditioner |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3765 |
| Establishment | Manufacturer |
| 510(k) | K990650 |
| Record published | 2016-09-27 |
| Record revised | 2025-01-13 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Handling environment atmospheric pressure 10 to 25 °C |
| Distribution end date | 2025-01-12 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| CONSEAL CLEAR 4 SYR KT | 4 | In distribution | |
| 7850012 | In distribution | ||
| 7850008 | In distribution | ||
| 7850013 | In distribution | ||
| 7850006 | In distribution | ||
| CONSEAL F SYR KT | 3 | Withdrawn | |
| CONSEAL F SYR BULK KT | 10 | Withdrawn | |
| CONSEAL F KT | 2 | Withdrawn | |
| CONSEAL F 5ML | Withdrawn |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 |
| 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.