Cleared Traditional

K791585 - MODEL G-61 ULTRASONIC DENTAL UNIT

K791585 is the FDA 510(k) clearance for MODEL G-61 ULTRASONIC DENTAL UNIT by Cavitron Corp.. It is a Class 2 Dental device (product code ELC) cleared through the Traditional 510(k) pathway after a 33-day FDA review.

K791585 · Cavitron Corp. · Dental device
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Sep 1979
Decision
33d
Days
Class 2
Risk

K791585 is an FDA 510(k) clearance for the MODEL G-61 ULTRASONIC DENTAL UNIT. Classified as Scaler, Ultrasonic (product code ELC), Class II - Special Controls.

Submitted by Cavitron Corp. (Mchenry, US). The FDA issued a Cleared decision on September 19, 1979 after a review of 33 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4850 - 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 Cavitron Corp. devices

Submission Details

510(k) Number K791585 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 17, 1979
Decision Date September 19, 1979
Days to Decision 33 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
94d faster than avg
Panel avg: 127d · This submission: 33d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code ELC Scaler, Ultrasonic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.4850
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.