Cleared Traditional

K942480 - M4 CONTRA-ANGLE HANDPIECE

K942480 is an FDA 510(k) clearance for M4 CONTRA-ANGLE HANDPIECE, manufactured by Kerr Corporation (Danbury). The device is a Class 1 Dental device with product code EGS cleared through the Traditional 510(k) pathway after a 247-day FDA review.

K942480 · Kerr Corporation (Danbury) · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1995
Decision
247d
Days
Class 1
Risk

K942480 is an FDA 510(k) clearance for the M4 CONTRA-ANGLE HANDPIECE. Classified as Handpiece, Contra- And Right-angle Attachment, Dental (product code EGS), Class I - General Controls.

Submitted by Kerr Corporation (Danbury) (Glendora, US). The FDA issued a Cleared decision on January 27, 1995 after a review of 247 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 Kerr Corporation (Danbury) devices

FDA 510(k) Submission Details - K942480

510(k) Number K942480 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 25, 1994
Decision Date January 27, 1995
Days to Decision 247 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
120d slower than avg
Panel avg: 127d · This submission: 247d
Pathway characteristics
Predicate-based equivalence.

EGS Device Classification - Class 1, General Controls

Product Code EGS Handpiece, Contra- And Right-angle Attachment, Dental
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 - EGS Handpiece, Contra- And Right-angle Attachment, Dental

All 46
Devices cleared under the same product code (EGS) and FDA review panel - the closest regulatory comparables to K942480.
SERIES XE 140XE,40XE,10XE/SERIES SE 140SE,40SE,10SE/SERIES 10TE
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ORAL PROCEDURE PACK
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PROPHYLAXIS PACK
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CANAL FINDER
K850294 · Roseburg SA · Jun 1985
TORX HANDPIECE CONTRA ANGLES ATTACHMENTS
K801688 · Pacific Dental Corp. · Aug 1980
HANDPIECE, LIFT, ENDO
K780213 · Kerr Corporation (Danbury) · Feb 1978