Cleared Traditional

K926081 - DENTAL LIGHT (FDA 510(k) Clearance)

Class I Dental device.

K926081 · Mdt Corp., Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1994
Decision
421d
Days
Class 1
Risk

K926081 is an FDA 510(k) clearance for the DENTAL LIGHT. Classified as Light, Operating, Dental (product code EAZ), Class I - General Controls.

Submitted by Mdt Corp., Inc. (Rochester, US). The FDA issued a Cleared decision on January 26, 1994 after a review of 421 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Dental submissions.

View all Mdt Corp., Inc. devices

Submission Details

510(k) Number K926081 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 01, 1992
Decision Date January 26, 1994
Days to Decision 421 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
294d slower than avg
Panel avg: 127d · This submission: 421d
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.