K181129 is an FDA 510(k) clearance for the STRONG Dental Handpieces. This device is classified as a Handpiece, Contra- And Right-angle Attachment, Dental (Class I - General Controls, product code EGS).
Submitted by Saeshin Precision Co., Ltd. (Deagu, KR). The FDA issued a Cleared decision on January 31, 2019, 276 days after receiving the submission on April 30, 2018.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4200.
| 510(k) Number | K181129 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 30, 2018 |
| Decision Date | January 31, 2019 |
| Days to Decision | 276 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Statement |
| Product Code | EGS - Handpiece, Contra- And Right-angle Attachment, Dental |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.4200 |