K131906 is an FDA 510(k) clearance for the SCANWAVE PEN (WITH LIGHT GRAY CORD), SCANWAVE PEN (WITH MEDIUM GRAY CORD), SCANWAVE PEN (WITH DARK GRAY CORD), SCANWAVE. This device is classified as a Activator, Ultraviolet, For Polymerization (Class II - Special Controls, product code EBZ).
Submitted by Satelec - Acteon Group (Mt. Laurel, US). The FDA issued a Cleared decision on April 11, 2014, 289 days after receiving the submission on June 26, 2013.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.6070.
| 510(k) Number | K131906 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 26, 2013 |
| Decision Date | April 11, 2014 |
| Days to Decision | 289 days |
| Submission Type | Abbreviated |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | EBZ - Activator, Ultraviolet, For Polymerization |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.6070 |