FluoroCal
FluoroCal - 3 Unit Dose Sample Pkg Assorted: 1 UDs of each flavor (Bubble Gum, Green Apple, & Spearmint)
1manufacturer
9catalogue numbers in this listing
2510(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 | Bisco, Inc., United States |
|---|---|
| FDA product code | LBH |
| Device type | Varnish, Cavity |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3260 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K182917 |
| Record published | 2023-12-11 |
| Record revised | 2022-11-18 (version 6) |
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 20 to 25 °C |
| Distribution end date | 2025-04-15 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| B-3001 | In distribution | ||
| B-30502K | 50 | Withdrawn | |
| B-3003PS | 3 | Withdrawn | |
| B-3004PS | Withdrawn | ||
| B-3003PS | Withdrawn | ||
| B-30501K | Withdrawn | ||
| B-30501K | 50 | Withdrawn | |
| B-30504K | 50 | Withdrawn | |
| B-30507K | Withdrawn |
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 |
|---|---|
| K182917 | 2019-11-18 |
| K123653 | 2013-06-03 |
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.