Cleared Traditional

LC DENTAL HAND INSTRUMENT (K935217) - FDA 510(k) Clearance

Class I Dental device.

K935217 · L.C. Dental · Dental device
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Jan 1994
Decision
71d
Days
Class 1
Risk

K935217 is an FDA 510(k) clearance for the LC DENTAL HAND INSTRUMENT. Classified as Burnisher, Operative (product code EKJ), Class I - General Controls.

Submitted by L.C. Dental (Campbell, US). The FDA issued a Cleared decision on January 5, 1994 after a review of 71 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4565 - 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 L.C. Dental devices

Submission Details

510(k) Number K935217 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 26, 1993
Decision Date January 05, 1994
Days to Decision 71 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
56d faster than avg
Panel avg: 127d · This submission: 71d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EKJ Burnisher, Operative
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.4565
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 - EKJ Burnisher, Operative

Devices cleared under the same product code (EKJ) and FDA review panel - the closest regulatory comparables to K935217.
SUREFLEX FILES
K951607 · Dentsply Intl. · Jun 1995
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DENTALVISION TV SYSTEM
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DISPOSABLE DENTAL PROBE/EXPLORER
K880590 · Baxter Healthcare Corp · Mar 1988