K963209 is an FDA 510(k) clearance for the PROSTYLE COMPACT. This device is classified as a Chair, Dental, With Operative Unit (Class I - General Controls, product code KLC).
Submitted by Planmeca Oy (Helsinki, FI). The FDA issued a Cleared decision on October 24, 1996, 69 days after receiving the submission on August 16, 1996.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.6250.
| 510(k) Number | K963209 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 16, 1996 |
| Decision Date | October 24, 1996 |
| Days to Decision | 69 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Statement |
| Product Code | KLC — Chair, Dental, With Operative Unit |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.6250 |