K180527 is an FDA 510(k) clearance for the IS3. This device is classified as a Handpiece, Direct Drive, Ac-powered (Class I - General Controls, product code EKX).
Submitted by Hiossen, Inc. (Fariless Hills, US). The FDA issued a Cleared decision on May 16, 2018, 77 days after receiving the submission on February 28, 2018.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4200.
| 510(k) Number | K180527 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 28, 2018 |
| Decision Date | May 16, 2018 |
| Days to Decision | 77 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | EKX — Handpiece, Direct Drive, Ac-powered |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.4200 |