Cleared Traditional

PROSTYLE COMPACT

K961420 · Planmeca Oy · Dental
Sep 1996
Decision
151d
Days
Class 1
Risk

About This 510(k) Submission

K961420 is an FDA 510(k) clearance for the PROSTYLE COMPACT, a Unit, Operative Dental (Class I — General Controls, product code EIA), submitted by Planmeca Oy (Helsinki, FI). The FDA issued a Cleared decision on September 10, 1996, 151 days after receiving the submission on April 12, 1996. This device falls under the Dental review panel. Regulated under 21 CFR 872.6640.

Submission Details

510(k) Number K961420 FDA.gov
FDA Decision Cleared SESE
Date Received April 12, 1996
Decision Date September 10, 1996
Days to Decision 151 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

Device Classification

Product Code EIA — Unit, Operative Dental
Device Class Class I — General Controls
CFR Regulation 21 CFR 872.6640

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