K132570 is an FDA 510(k) clearance for the ELECTRIC HANDPIECE SYSTEM. This device is classified as a Controller, Foot, Handpiece And Cord (Class I - General Controls, product code EBW).
Submitted by Ttbio Corp. (Taichung, Roc, TW). The FDA issued a Cleared decision on April 29, 2014, 257 days after receiving the submission on August 15, 2013.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4200.
| 510(k) Number | K132570 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 15, 2013 |
| Decision Date | April 29, 2014 |
| Days to Decision | 257 days |
| Submission Type | Abbreviated |
| 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 |