The following data is part of a premarket notification filed by Elevate Oral Care with the FDA for Smartcoat 2.5% Naf Varnish.
| Device ID | K131376 |
| 510k Number | K131376 |
| Device Name: | SMARTCOAT 2.5% NAF VARNISH |
| Classification | Varnish, Cavity |
| Applicant | ELEVATE ORAL CARE 346 PIKE ROAD SUITE 5 West Palm Beach, FL 33411 |
| Contact | Steve Pardue |
| Correspondent | Steve Pardue ELEVATE ORAL CARE 346 PIKE ROAD SUITE 5 West Palm Beach, FL 33411 |
| Product Code | LBH |
| CFR Regulation Number | 872.3260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-05-14 |
| Decision Date | 2013-08-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00858290006222 | K131376 | 000 |
| 00858290006765 | K131376 | 000 |
| 00858290006772 | K131376 | 000 |
| 00858290006789 | K131376 | 000 |
| 00858290006796 | K131376 | 000 |
| 00858290006307 | K131376 | 000 |
| 00858290006079 | K131376 | 000 |
| 00858290006086 | K131376 | 000 |
| 00858290006093 | K131376 | 000 |
| 00858290006109 | K131376 | 000 |
| 00858290006116 | K131376 | 000 |
| 00858290006123 | K131376 | 000 |
| 00858290006147 | K131376 | 000 |
| 00858290006154 | K131376 | 000 |
| 00858290006215 | K131376 | 000 |
| 00858290006758 | K131376 | 000 |