Waterpik Ultra Thin & Clear Varnish
5% Sodium Fluoride, Variety Pack - 25 ea - Bubblegum, Melon, Strawberry, and Mint flavors
1manufacturer
18catalogue numbers in this listing
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 | Water PIK, Inc., United States |
|---|---|
| FDA product code | LBH |
| Device type | Varnish, Cavity |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3260 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K040098 |
| Record published | 2023-08-18 |
| Record revised | 2024-03-20 (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 |
| Storage | Storage environment temperature 68 to 77 °F |
| Sizes | Total volume 0.4 ml |
| Distribution end date | 2025-09-15 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 20032770 | Total Volume 0.40 ml | 100 | Withdrawn |
| 20032763 | Total Volume 0.40 ml | 30 | Withdrawn |
| 20032769 | Total Volume 0.40 ml | 100 | Withdrawn |
| 20032765 | Total Volume 0.40 ml | 30 | Withdrawn |
| 20032762 | Total Volume 0.40 ml | 30 | Withdrawn |
| 20032764 | Total Volume 0.40 ml | 30 | Withdrawn |
| 20030673 | Total Volume 0.40 ml | 100 | Withdrawn |
| 20032768 | Total Volume 0.40 ml | 100 | Withdrawn |
| 20030672 | Total Volume 0.40 ml | 100 | Withdrawn |
| 20030676 | Total Volume 0.40 ml | 30 | Withdrawn |
| 20030669 | Total Volume 0.40 ml | 100 | Withdrawn |
| 20030675 | Total Volume 0.40 ml | 30 | Withdrawn |
| 20032766 | Total Volume 0.40 ml | 100 | Withdrawn |
| 20030671 | Total Volume 0.40 ml | 100 | Withdrawn |
| 20030670 | Total Volume 0.40 ml | 100 | Withdrawn |
| 20030677 | Total Volume 0.40 ml | 30 | Withdrawn |
| 20030674 | Total Volume 0.40 ml | 30 | Withdrawn |
| 20032767 | Total Volume 0.40 ml | 100 | Withdrawn |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 |
| Premier | Premier Dental Products Co. | 17 |
| D-Lish | Young Dental Manufacturing I, LLC | 17 |
Showing 12 of 282. All products under Varnish, Cavity
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.