Submission Details
| 510(k) Number | K143183 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 05, 2014 |
| Decision Date | February 17, 2015 |
| Days to Decision | 104 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
Cleared
Traditional
K143183 - Maxima XTEND Handpiece Maintenance System
(FDA 510(k) Clearance)
Feb 2015
Decision
104d
Days
Class 1
Risk
K143183 is an FDA 510(k) clearance for the Maxima XTEND Handpiece Maintenance System, a Handpiece, Air-powered, Dental (Class I — General Controls, product code EFB), submitted by Handpiece Headquarters (Placentia, US). The FDA issued a Cleared decision on February 17, 2015, 104 days after receiving the submission on November 5, 2014. This device falls under the Dental review panel. Regulated under 21 CFR 872.4200.
Device Classification
| Product Code | EFB — Handpiece, Air-powered, Dental |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 872.4200 |
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