Henry Schein
ACCLEAN ONE STEP FLUORIDE VARNISH BUBBLE GUM -200ct
1manufacturer
19catalogue 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 | Henry Schein, Inc., United States |
|---|---|
| FDA product code | LBH |
| Device type | Varnish, Cavity |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3260 |
| Record published | 2016-09-24 |
| Record revised | 2019-02-07 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Storage environment temperature 59 to 86 °F |
| Packaging | Case of 45, case of 8, pack of 12, pack of 24, kit of 14 |
| Sizes | Total volume 0.4 ml |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 1127170 | 200 | In distribution | |
| 1127169 | 50 | In distribution | |
| 5700531 | Total Volume 0.4 ml | 50 | In distribution |
| 5700528 | Total Volume 0.4 ml | 50 | In distribution |
| 1125999 | 200 | In distribution | |
| 5700524 | Total Volume 0.4 ml | 200 | In distribution |
| 5700525 | Total Volume 0.4 ml | 200 | In distribution |
| 5700523 | Total Volume 0.4 ml | 200 | In distribution |
| 1124869 | 50 | In distribution | |
| 5700532 | Total Volume 0.4 ml | 50 | In distribution |
| 1125994 | In distribution | ||
| 1124868 | 50 | In distribution | |
| 1126001 | 200 | In distribution | |
| 5700526 | Total Volume 0.4 ml | 200 | In distribution |
| 5700527 | Total Volume 0.4 ml | 200 | In distribution |
| 1125963 | 50 | In distribution | |
| 5700529 | Total Volume 0.4 ml | 50 | In distribution |
| 1125998 | 200 | In distribution | |
| 5700530 | Total Volume 0.4 ml | 50 | 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 |
| Waterpik Ultra Thin & Clear Varnish | Water PIK, Inc. | 18 |
| 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.