FluroShield® Visible Light Cure Pit & Fissure Sealant
FluroShield® Visible Light Cure Pit & Fissure Sealant Standard Package, Tooth Colored
1manufacturer
2catalogue numbers in this listing
12510(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 | Dentsply LLC, 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, Exporter |
| 510(k) | K896341 |
| Record published | 2016-09-21 |
| Record revised | 2018-07-06 (version 3) |
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 |
| Storage | Special storage condition: Refrigerate upon receipt. Keep away from sunlight. Keep dry.; Storage environment temperature 2 to 8 °C |
| Sizes | Total volume 10 ml; weight 5 g |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 643300 | Total Volume 10 ml | In distribution |
| 643350 | Weight 5 g | 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 |
| 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 |
|---|---|
| K050959 | 2005-05-11 |
| K992519 | 1999-10-22 |
| K992518 | 1999-09-22 |
| K992516 | 1999-08-27 |
| K991909 | 1999-08-20 |
| K982564 | 1998-10-06 |
| K951296 | 1995-05-03 |
| K896341 | 1990-04-23 |
| K874944 | 1988-02-08 |
| K862660 | 1986-07-31 |
| K844308 | 1985-01-09 |
| K802562 | 1980-11-12 |
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.