Cleared Traditional

K772351 - DENTAL LIGHT

K772351 is an FDA 510(k) clearance for DENTAL LIGHT, manufactured by Chemetron Dental Products. The device is a Class 1 Dental device with product code EAZ cleared through the Traditional 510(k) pathway after a 26-day FDA review.

K772351 · Chemetron Dental Products · Dental device
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Jan 1978
Decision
26d
Days
Class 1
Risk

K772351 is an FDA 510(k) clearance for the DENTAL LIGHT. Classified as Light, Operating, Dental (product code EAZ), Class I - General Controls.

Submitted by Chemetron Dental Products (Mchenry, US). The FDA issued a Cleared decision on January 17, 1978 after a review of 26 days - a notably fast clearance cycle.

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: 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 Chemetron Dental Products devices

FDA 510(k) Submission Details - K772351

510(k) Number K772351 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 1977
Decision Date January 17, 1978
Days to Decision 26 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
102d faster than avg
Panel avg: 128d · This submission: 26d
Pathway characteristics
Predicate-based equivalence.

EAZ Device Classification - Class 1, General Controls

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.