Cleared Traditional

RITTER STARLIGHT DENTAL OPERATING LIGHT (K760707) - FDA 510(k) Clearance

Class I Dental device.

K760707 · Ritter Co. · Dental device
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Oct 1976
Decision
12d
Days
Class 1
Risk

K760707 is an FDA 510(k) clearance for the RITTER STARLIGHT DENTAL OPERATING LIGHT. Classified as Light, Operating, Dental (product code EAZ), Class I - General Controls.

Submitted by Ritter Co. (Mchenry, US). The FDA issued a Cleared decision on October 5, 1976 after a review of 12 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 Ritter Co. devices

Submission Details

510(k) Number K760707 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 23, 1976
Decision Date October 05, 1976
Days to Decision 12 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
115d faster than avg
Panel avg: 127d · This submission: 12d
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.