K180935 is an FDA 510(k) clearance for the Infinity / Infinity Cross Flex Dental Systems. This device is classified as a Unit, Operative Dental (Class I - General Controls, product code EIA).
Submitted by Olsen Industria E Comercio S.A. (Palhoça -, BR). The FDA issued a Cleared decision on February 5, 2020, 666 days after receiving the submission on April 10, 2018.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.6640.
| 510(k) Number | K180935 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 10, 2018 |
| Decision Date | February 05, 2020 |
| Days to Decision | 666 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Statement |
| Product Code | EIA - Unit, Operative Dental |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.6640 |