Cleared Traditional

K932600 - MODIFIED SITE POWER HANDPIECE II

K932600 is an FDA 510(k) clearance for MODIFIED SITE POWER HANDPIECE II, manufactured by Chiron Vision Corp.. The device is a Class 1 Dental device with product code EKX cleared through the Traditional 510(k) pathway after a 242-day FDA review.

K932600 · Chiron Vision Corp. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1994
Decision
242d
Days
Class 1
Risk

K932600 is an FDA 510(k) clearance for the MODIFIED SITE POWER HANDPIECE II. Classified as Handpiece, Direct Drive, Ac-powered (product code EKX), Class I - General Controls.

Submitted by Chiron Vision Corp. (Horsham, US). The FDA issued a Cleared decision on January 25, 1994 after a review of 242 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4200 - 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 Chiron Vision Corp. devices

FDA 510(k) Submission Details - K932600

510(k) Number K932600 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 28, 1993
Decision Date January 25, 1994
Days to Decision 242 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
115d slower than avg
Panel avg: 127d · This submission: 242d
Pathway characteristics
Predicate-based equivalence.

EKX Device Classification - Class 1, General Controls

Product Code EKX Handpiece, Direct Drive, Ac-powered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.4200
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 - EKX Handpiece, Direct Drive, Ac-powered

All 69
Devices cleared under the same product code (EKX) and FDA review panel - the closest regulatory comparables to K932600.
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TRI AUTO ZX
K970339 · J. Morita USA, Inc. · Jun 1997
FRESENIUS PD+ EXCHANGE DEVICE
K915634 · Fresenius USA, Inc. · Jul 1993
MODIFIED SITE POWER HANDPIECE
K922077 · Chiron Vision Corp. · Jun 1992
PERIOTEST
K872171 · Siemens Medical Solutions USA, Inc. · Jun 1987