K163131 is an FDA 510(k) clearance for the A-dec NLZ Electric Motor System. This device is classified as a Controller, Foot, Handpiece And Cord (Class I - General Controls, product code EBW).
Submitted by Nakanishi, Inc. (Kanuma, JP). The FDA issued a Cleared decision on May 11, 2017, 184 days after receiving the submission on November 8, 2016.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4200.
| 510(k) Number | K163131 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 08, 2016 |
| Decision Date | May 11, 2017 |
| Days to Decision | 184 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 |