SciPharm Fluoroseal Cavity Liner
Fluoroseal is a Light-Cured Cavity Liner used for Building the Cavity Floor in Deep Restorations. Also Provide Protection Against Irritants from Restoratives or Auxiliary Materials. Dentin…
Fluoroseal is a Light-Cured Cavity Liner used for Building the Cavity Floor in Deep Restorations. Also Provide Protection Against Irritants from Restoratives or Auxiliary Materials. Dentin Shade Syringe. Trial Size. Boxed.
1manufacturer
15catalogue numbers in this listing
9510(k) clearances naming this product code
Who Else Makes It
Registered in Hebei.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| CAO (China) Medical Equipment Company, Limited | Langfang | Hebei | Contract manufacturer | 6 |
Record
| Listed by | Scientific Pharmaceuticals, Inc., United States |
|---|---|
| FDA product code | LBH |
| Device type | Varnish, Cavity |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3260 |
| Establishment | Contract manufacturer, Manufacturer |
| 510(k) | K860633 |
| Record published | 2016-08-11 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| 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 75-035 Z | In distribution | |
| SP 75-031 NB | In distribution | |
| SP 75-131 B | In distribution | |
| SP 75-131 BS | In distribution | |
| SP 75-131 N | In distribution | |
| SP 75-031 B | In distribution | |
| SP 75-036 B | In distribution | |
| SP 75-036 B | In distribution | |
| SP 75-035 B | In distribution | |
| SP 75-03 S | In distribution | |
| SP 75-031 | In distribution | |
| SP 75-035 BS | In distribution | |
| SP 75-031 BS | In distribution | |
| SP 75-13 | In distribution | |
| SP 75-035 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| NovaBright | Nanova BIO Materials Inc | 46 |
| Enamelast | Ultradent Products Inc. | 41 |
| Nupro® | Dentsply Professional | 34 |
| Fluorodose | Centrix, Inc. | 26 |
| VarnishAmerica | Medical Products Laboratories, Inc. | 24 |
| Voco Profluorid Varnish | Voco Gmbh | 23 |
| Profisil | Kettenbach Gmbh & Co KG | 23 |
| Starbright | Nanova BIO Materials Inc | 22 |
| Wonderful Dental | Roses and Rubies, LLC | 19 |
| Henry Schein | Henry Schein, Inc. | 19 |
| Waterpik Ultra Thin & Clear Varnish | Water PIK, Inc. | 18 |
| Premier | Premier Dental Products Co. | 17 |
Showing 12 of 282. All products under Varnish, Cavity
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K192381 | 2020-02-18 |
| K982915 | 1999-02-12 |
| K983305 | 1998-12-17 |
| K900946 | 1990-05-25 |
| K860633 | 1986-04-11 |
| K852755 | 1985-09-23 |
| K852756 | 1985-07-31 |
| K802926 | 1980-12-19 |
| K800438 | 1980-03-12 |
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.