Cleared Traditional

K961420 - PROSTYLE COMPACT

K961420 is the FDA 510(k) clearance for PROSTYLE COMPACT by Planmeca Oy. It is a Class 1 Dental device (product code EIA) cleared through the Traditional 510(k) pathway after a 151-day FDA review.

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

K961420 is an FDA 510(k) clearance for the PROSTYLE COMPACT. Classified as Unit, Operative Dental (product code EIA), Class I - General Controls.

Submitted by Planmeca Oy (Helsinki, FI). The FDA issued a Cleared decision on September 10, 1996 after a review of 151 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6640 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Planmeca Oy devices

Submission Details

510(k) Number K961420 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
24d slower than avg
Panel avg: 127d · This submission: 151d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EIA Unit, Operative Dental
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.6640
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 - EIA Unit, Operative Dental

All 61
Devices cleared under the same product code (EIA) and FDA review panel - the closest regulatory comparables to K961420.
KSEA ENDOSCOPES FOR DENTAL PROCEDURES
K982658 · KARL STORZ Endoscopy-America, Inc. · Oct 1998
WELCH ALLYN REVEAL INTRAORAL CAMERA SYSTEM
K981937 · Welch Allyn, Inc. · Aug 1998
DENTAL TRAY, STERILE, DISPOSABLE
K974238 · Trinity Laboratories, Inc. · Feb 1998
A-DEC SELF-CONTAINED WATER SYSTEM
K962665 · A-Dec, Inc. · Aug 1996
A-DEC PERFORMER CONTROL UNIT
K960506 · A-Dec, Inc. · Mar 1996
A-DEC RADIUS 2122/2132
K940893 · A-Dec, Inc. · Jul 1994