Cleared Traditional

K932600 - MODIFIED SITE POWER HANDPIECE II

K932600 is the FDA 510(k) clearance for MODIFIED SITE POWER HANDPIECE II by Chiron Vision Corp.. It is a Class 1 Dental device (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

Submission Details

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.

Device Classification

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 45
Devices cleared under the same product code (EKX) and FDA review panel - the closest regulatory comparables to K932600.
QUANTEC-E ENDO SYSTEM
K990739 · Sybron Dental Specialties, Inc. · May 1999
MODEL MS-1 HANDPIECE
K983413 · Parkell, Inc. · Dec 1998
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