Cleared Traditional

K963209 - PROSTYLE COMPACT

K963209 is an FDA 510(k) clearance for PROSTYLE COMPACT, manufactured by Planmeca Oy. The device is a Class 1 Dental device with product code KLC cleared through the Traditional 510(k) pathway after a 69-day FDA review.

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

K963209 is an FDA 510(k) clearance for the PROSTYLE COMPACT. Classified as Chair, Dental, With Operative Unit (product code KLC), Class I - General Controls.

Submitted by Planmeca Oy (Helsinki, FI). The FDA issued a Cleared decision on October 24, 1996 after a review of 69 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6250 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K963209

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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
59d faster than avg
Panel avg: 128d · This submission: 69d
Pathway characteristics
Predicate-based equivalence.

KLC Device Classification - Class 1, General Controls

Product Code KLC Chair, Dental, With Operative Unit
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.6250
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - KLC Chair, Dental, With Operative Unit

All 61
Devices cleared under the same product code (KLC) and FDA review panel - the closest regulatory comparables to K963209.
DCI Edge Dental Chair with Operative Unit
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K971063 · King Dental Corp. · Jun 1997
ULTIMA 2 DENTAL CHAIR
K942870 · Dentech Corp. · Feb 1995
KAVO SYSTEMATICA 1060
K940950 · Kavo America · Dec 1994
E 4000 DENTAL OPERATING CHAIR
K925567 · Dentalez Group · Mar 1994
K963209 · PROSTYLE COMPACT
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