Enamelast
Enamelast 0.4ml Syringe 200pk - Walterberry
1manufacturer
41catalogue numbers in this listing
9510(k) clearances naming this product code
1recall
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 | Ultradent Products Inc., United States |
|---|---|
| FDA product code | LBH |
| Device type | Varnish, Cavity |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3260 |
| Establishment | Contract manufacturer, Repacker / relabeller, Manufacturer |
| Record published | 2025-11-14 |
| Record revised | 2022-08-16 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 2 to 27 °C |
| Distribution end date | 2018-09-05 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 6898 | In distribution | |
| 4354 | In distribution | |
| 6913 | In distribution | |
| 4528 | In distribution | |
| 4518 | In distribution | |
| 6897 | In distribution | |
| 4364 | In distribution | |
| 4344 | In distribution | |
| 4362 | In distribution | |
| 4819 | In distribution | |
| 6896 | In distribution | |
| 6906 | In distribution | |
| 4353 | In distribution | |
| 4821 | In distribution | |
| 5188 | In distribution | |
| 6907 | In distribution | |
| 4822 | In distribution | |
| 4352 | In distribution | |
| 5187 | In distribution | |
| 4526 | In distribution | |
| 6908 | In distribution | |
| 4345 | In distribution | |
| 4343 | In distribution | |
| 6910 | In distribution | |
| 4531 | In distribution | |
| 6909 | In distribution | |
| 4363 | In distribution | |
| 6911 | In distribution | |
| 4521 | In distribution | |
| S4519 | In distribution | |
| 6912 | In distribution | |
| 4368 | In distribution | |
| S4519 | In distribution | |
| 4523 | In distribution | |
| 6895 | In distribution | |
| 4348 | Withdrawn | |
| 4349 | Withdrawn | |
| 4347 | Withdrawn | |
| 4367 | Withdrawn | |
| 4366 | Withdrawn | |
| 4346 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| NovaBright | Nanova BIO Materials Inc | 46 |
| 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 |
| D-Lish | Young Dental Manufacturing I, LLC | 17 |
Showing 12 of 282. All products under Varnish, Cavity
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K261404 | 2026-04-30 |
| K080249 | 2008-02-08 |
| K061438 | 2007-06-12 |
| K051750 | 2005-09-19 |
| K963979 | 1996-12-12 |
| K953168 | 1995-09-08 |
| K953167 | 1995-09-08 |
| K925375 | 1993-07-22 |
| K924982 | 1993-07-08 |
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2018-07-12 | Class II | Mixed-up of materials/components | Dental varnish has the possibility of having an unpleasant and off flavor. | 1654 units | 2019-02-19 |
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.