Cleared Traditional

K925629 - ACCESSORY TO IMPROVED DENTAL OPERATING LIGHT (FDA 510(k) Clearance)

Class I Dental device.

K925629 · Den-Tal-Ez Mfg Co., Inc. · Dental device
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Nov 1993
Decision
382d
Days
Class 1
Risk

K925629 is an FDA 510(k) clearance for the ACCESSORY TO IMPROVED DENTAL OPERATING LIGHT. Classified as Light, Operating, Dental (product code EAZ), Class I - General Controls.

Submitted by Den-Tal-Ez Mfg Co., Inc. (Lancaster, US). The FDA issued a Cleared decision on November 23, 1993 after a review of 382 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4630 - 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. Elevated predicate reliance profile. 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 Den-Tal-Ez Mfg Co., Inc. devices

Submission Details

510(k) Number K925629 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 06, 1992
Decision Date November 23, 1993
Days to Decision 382 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
255d slower than avg
Panel avg: 127d · This submission: 382d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EAZ Light, Operating, Dental
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.4630
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.