SciPharm Pit & Fissure Sealer Bonding Agent
Light-Cured Resin for Sealing Occlusal Fissures and for Bonding Composite Restoratives to Etched Enamel. White Opaque with Green Etching Agent.
1manufacturer
20catalogue numbers in this listing
2510(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 | Scientific Pharmaceuticals, 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, Manufacturer |
| 510(k) | K813091 |
| Record published | 2016-08-09 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Storage environment temperature up to 75 °F |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SP 56-01 | In distribution | |
| SP 53-01 | In distribution | |
| SP 54-011 B | In distribution | |
| SP 54-01 | In distribution | |
| SP 52-01 S | In distribution | |
| SP 54-011 N | In distribution | |
| SP 54-01 S | In distribution | |
| SP 52-011 | In distribution | |
| SP 53-01 S | In distribution | |
| SP 56-011 B | In distribution | |
| SP 56-011 N | In distribution | |
| SP 53-011 | In distribution | |
| SP 52-01 | In distribution | |
| SP 56-01 CH | In distribution | |
| SP 51-01 S | In distribution | |
| SP 51-01 | In distribution | |
| SP 52-012 | In distribution | |
| SP 52-011 B | In distribution | |
| SP 56-01 S | In distribution | |
| SP 52-012 B | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| UltraSeal XT | Ultradent Products Inc. | 22 |
| 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 |
| Enamel Coating Resin | Rizhao Huge Biomaterials Company, Ltd. | 6 |
Showing 12 of 133. All products under Sealant, Pit And Fissure, And Conditioner
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K843098 | 1984-09-07 |
| K790788 | 1979-07-06 |
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.