Cleared Traditional

K821739 - J. MORITA FLEX M-3 TORX HARDPIECE

K821739 is an FDA 510(k) clearance for J. MORITA FLEX M-3 TORX HARDPIECE, manufactured by Pacific Dental Corp.. The device is a Class 1 Dental device with product code EKX cleared through the Traditional 510(k) pathway after a 11-day FDA review.

K821739 · Pacific Dental Corp. · Dental device
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Jun 1982
Decision
11d
Days
Class 1
Risk

K821739 is an FDA 510(k) clearance for the J. MORITA FLEX M-3 TORX HARDPIECE. Classified as Handpiece, Direct Drive, Ac-powered (product code EKX), Class I - General Controls.

Submitted by Pacific Dental Corp. (Mchenry, US). The FDA issued a Cleared decision on June 25, 1982 after a review of 11 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Pacific Dental Corp. devices

FDA 510(k) Submission Details - K821739

510(k) Number K821739 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 14, 1982
Decision Date June 25, 1982
Days to Decision 11 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
116d faster than avg
Panel avg: 127d · This submission: 11d
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 47
Devices cleared under the same product code (EKX) and FDA review panel - the closest regulatory comparables to K821739.
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
TORX MICRO-MOTOR LOW SPEED HANDPIECE
K801687 · Pacific Dental Corp. · Aug 1980
PERITONEAL DIALYSIS SYSTEM
K760724 · Physio-Control Corp. · Nov 1976