K231864 is an FDA 510(k) clearance for the Fiber Optic Brushless Electronic Micromotor, model: iM100. This device is classified as a Controller, Foot, Handpiece And Cord (Class I - General Controls, product code EBW).
Submitted by Codent Technical Industry Co., Ltd. (Kaohsiung City, TW). The FDA issued a Cleared decision on March 11, 2024, 259 days after receiving the submission on June 26, 2023.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4200.
| 510(k) Number | K231864 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 26, 2023 |
| Decision Date | March 11, 2024 |
| Days to Decision | 259 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 |