K192688 is an FDA 510(k) clearance for the s-Clean SQ-SL Implant System Regular. This device is classified as a Implant, Endosseous, Root-form (Class II - Special Controls, product code DZE).
Submitted by Dentis Co., Ltd. (Daegu, KR). The FDA issued a Cleared decision on February 4, 2020, 131 days after receiving the submission on September 26, 2019.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3640.
| 510(k) Number | K192688 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 26, 2019 |
| Decision Date | February 04, 2020 |
| Days to Decision | 131 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | DZE — Implant, Endosseous, Root-form |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3640 |