K152064 is an FDA 510(k) clearance for the Astringedent Clear. This device is classified as a Cord, Retraction.
Submitted by Ultradent Products, Inc. (South Jordan, US). The FDA issued a Cleared decision on September 24, 2015, 62 days after receiving the submission on July 24, 2015.
This device falls under the Dental FDA review panel.
| 510(k) Number | K152064 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 24, 2015 |
| Decision Date | September 24, 2015 |
| Days to Decision | 62 days |
| Submission Type | Special |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | MVL — Cord, Retraction |
| Device Class | — |