Cleared Traditional

K760805 - ULTRASONIC DENTAL PROPHYLAXIS DEVICE

K760805 is the FDA 510(k) clearance for ULTRASONIC DENTAL PROPHYLAXIS DEVICE by Cavitron Corp.. It is a Class 2 Dental device (product code ELC) cleared through the Traditional 510(k) pathway after a 9-day FDA review.

K760805 · Cavitron Corp. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1976
Decision
9d
Days
Class 2
Risk

K760805 is an FDA 510(k) clearance for the ULTRASONIC DENTAL PROPHYLAXIS DEVICE. Classified as Scaler, Ultrasonic (product code ELC), Class II - Special Controls.

Submitted by Cavitron Corp. (Mchenry, US). The FDA issued a Cleared decision on October 21, 1976 after a review of 9 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 K760805 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 12, 1976
Decision Date October 21, 1976
Days to Decision 9 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
118d faster than avg
Panel avg: 127d · This submission: 9d
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.