K101346 is an FDA 510(k) clearance for the GC ORAL MOISTURIZING GEL. This device is classified as a Saliva, Artificial.
Submitted by GC America, Inc. (Alsip, US). The FDA issued a Cleared decision on January 27, 2011, 259 days after receiving the submission on May 13, 2010.
This device falls under the Dental FDA review panel.
| 510(k) Number | K101346 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 13, 2010 |
| Decision Date | January 27, 2011 |
| Days to Decision | 259 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | LFD — Saliva, Artificial |
| Device Class | — |