The following data is part of a premarket notification filed by Planmeca Oy with the FDA for Prostyle Compact.
| Device ID | K963209 |
| 510k Number | K963209 |
| Device Name: | PROSTYLE COMPACT |
| Classification | Chair, Dental, With Operative Unit |
| Applicant | PLANMECA OY ASENTAJANKATU 6 Helsinki, FI 00880 |
| Contact | Lars Moring |
| Correspondent | Lars Moring PLANMECA OY ASENTAJANKATU 6 Helsinki, FI 00880 |
| Product Code | KLC |
| CFR Regulation Number | 872.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-08-16 |
| Decision Date | 1996-10-24 |