K230246 is an FDA 510(k) clearance for the Dentis s-Clean SQ-SL Narrow Implant System. This device is classified as a Abutment, Implant, Dental, Endosseous (Class II - Special Controls, product code NHA).
Submitted by Dentis Co., Ltd. (Daegu, KR). The FDA issued a Cleared decision on May 25, 2023, 115 days after receiving the submission on January 30, 2023.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3630. To Be Used In Conjunction With An Endosseous Dental Implant Fixture To Aid In Prosthetic Rehabilitation..
| 510(k) Number | K230246 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 30, 2023 |
| Decision Date | May 25, 2023 |
| Days to Decision | 115 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | NHA — Abutment, Implant, Dental, Endosseous |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3630 |
| Definition | To Be Used In Conjunction With An Endosseous Dental Implant Fixture To Aid In Prosthetic Rehabilitation. |