Cleared Traditional

PROSTYLE COMPACT

K963209 · Planmeca Oy · Dental
Oct 1996
Decision
69d
Days
Class 1
Risk

About This 510(k) Submission

K963209 is an FDA 510(k) clearance for the PROSTYLE COMPACT, 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 review panel. Regulated under 21 CFR 872.6250.

Submission Details

510(k) Number K963209 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code KLC — Chair, Dental, With Operative Unit
Device Class Class I — General Controls
CFR Regulation 21 CFR 872.6250

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