K193341 is an FDA 510(k) clearance for the iCTmotor (WL-1). This device is classified as a Controller, Foot, Handpiece And Cord (Class I - General Controls, product code EBW).
Submitted by Dentium Co., Ltd. (Suwon-Si, KR). The FDA issued a Cleared decision on September 4, 2020, 276 days after receiving the submission on December 3, 2019.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4200.
| 510(k) Number | K193341 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 03, 2019 |
| Decision Date | September 04, 2020 |
| Days to Decision | 276 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | EBW - Controller, Foot, Handpiece And Cord |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.4200 |