Iris
Iris 5% NAF VARNISH - White Bubble Gum (200)
1manufacturer
17catalogue 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 | Benco Dental Supply Co. |
|---|---|
| FDA product code | LBH |
| Device type | Varnish, Cavity |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3260 |
| Premarket notification | Exempt |
| Record published | 2016-09-23 |
| Record revised | 2019-02-07 (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 |
| Packaging | Case of 56, case of 3, case of 14, case of 72, case of 12, 12 of 12 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 4846-428 | In distribution | |
| 4846-419 | In distribution | |
| 4699-294 | In distribution | |
| 3846-377 | In distribution | |
| 4846-400 | In distribution | |
| 4846-446 | In distribution | |
| 3844-584 | In distribution | |
| 4323-635 | In distribution | |
| 4699-285 | In distribution | |
| 4846-384 | In distribution | |
| 4699-301 | In distribution | |
| 4699-356 | In distribution | |
| 4005-961 | In distribution | |
| 3844-593 | In distribution | |
| 3846-368 | In distribution | |
| 4846-437 | In distribution | |
| 4323-617 | 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 |
| 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
Recalls Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Young Dental Manufacturing Co 1, LLC. | UDI-DI | 2023-05-23 | Class II | Employee error | The Iris 5% Fluoride Varnish White Mint package lot 207540 may contain units of 5% Fluoride Varnish Bubblegum. | 344 boxes |
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.