K141125 is an FDA 510(k) clearance for the U-TYPE CONTRA ANGLE, U-TYPE SECTIONAL CONTRA ANGLE. This device is classified as a Handpiece, Contra- And Right-angle Attachment, Dental (Class I - General Controls, product code EGS).
Submitted by Handpiece Headquarters (Placentia, US). The FDA issued a Cleared decision on October 23, 2014, 175 days after receiving the submission on May 1, 2014.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4200.
| 510(k) Number | K141125 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 01, 2014 |
| Decision Date | October 23, 2014 |
| Days to Decision | 175 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | EGS — Handpiece, Contra- And Right-angle Attachment, Dental |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.4200 |