K863484 is an FDA 510(k) clearance for the SIEMENS SIRONA(R) DENTAL CHAIR. This device is classified as a Chair, Dental, With Operative Unit (Class I - General Controls, product code KLC).
Submitted by Pelton & Crane Co. (Charlotte, US). The FDA issued a Cleared decision on September 19, 1986, 10 days after receiving the submission on September 9, 1986.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.6250.
| 510(k) Number | K863484 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 09, 1986 |
| Decision Date | September 19, 1986 |
| Days to Decision | 10 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | — |
| Product Code | KLC — Chair, Dental, With Operative Unit |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.6250 |