Premier
EP Varnish Clear-Straw 'N Cream .40 ml (200)
1manufacturer
17catalogue numbers in this listing
1510(k) clearance
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 | Premier Dental Products Co., United States |
|---|---|
| FDA product code | LBH |
| Device type | Varnish, Cavity |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3260 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K062683 |
| Record published | 2016-09-19 |
| Record revised | 2025-07-17 (version 4) |
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 |
| Distribution end date | 2025-07-16 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 9007535 | In distribution | |
| 9007581 | In distribution | |
| 9007582 | In distribution | |
| 9007580 | In distribution | |
| 9007548 | In distribution | |
| 9007589 | In distribution | |
| 9046074 | In distribution | |
| 9007534 | In distribution | |
| 9007549 | In distribution | |
| 9007533 | In distribution | |
| 9007542 | Withdrawn | |
| 9007541 | Withdrawn | |
| 9007544 | Withdrawn | |
| 9007545 | Withdrawn | |
| 9007543 | Withdrawn | |
| 9007547 | Withdrawn | |
| 9007540 | Withdrawn |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 |
| D-Lish | Young Dental Manufacturing I, LLC | 17 |
Showing 12 of 282. All products under Varnish, Cavity
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K062683 | 2006-11-21 |
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.