Cleared Traditional

K920017 - IMPROVED DENTAL OPERATING LIGHT (FDA 510(k) Clearance)

Class I Dental device.

K920017 · Den-Tal-Ez Mfg Co., Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1992
Decision
60d
Days
Class 1
Risk

K920017 is an FDA 510(k) clearance for the IMPROVED DENTAL OPERATING LIGHT. Classified as Chair, Dental, With Operative Unit (product code KLC), Class I - General Controls.

Submitted by Den-Tal-Ez Mfg Co., Inc. (Lancaster, US). The FDA issued a Cleared decision on March 2, 1992 after a review of 60 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6250 - 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 Den-Tal-Ez Mfg Co., Inc. devices

Submission Details

510(k) Number K920017 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 02, 1992
Decision Date March 02, 1992
Days to Decision 60 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
67d faster than avg
Panel avg: 127d · This submission: 60d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KLC Chair, Dental, With Operative Unit
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.6250
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.