K151987 is an FDA 510(k) clearance for the DCI Edge Dental Chair with Operative Unit. This device is classified as a Chair, Dental, With Operative Unit (Class I - General Controls, product code KLC).
Submitted by Dci (Newberg, US). The FDA issued a Cleared decision on June 1, 2016, 320 days after receiving the submission on July 17, 2015.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.6250.
| 510(k) Number | K151987 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 17, 2015 |
| Decision Date | June 01, 2016 |
| Days to Decision | 320 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | KLC — Chair, Dental, With Operative Unit |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.6250 |