K061331 is an FDA 510(k) clearance for the ORAL BALANCE LIQUID/ GEL. This device is classified as a Saliva, Artificial.
Submitted by Laclede, Inc. (Rancho Dominguez, US). The FDA issued a Cleared decision on July 25, 2006, 74 days after receiving the submission on May 12, 2006.
This device falls under the Dental FDA review panel.
| 510(k) Number | K061331 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 12, 2006 |
| Decision Date | July 25, 2006 |
| Days to Decision | 74 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | LFD - Saliva, Artificial |
| Device Class | - |