Cleared Traditional

K780811 - DENTAL ABRASIVE DEVICE (FDA 510(k) Clearance)

Class I Dental device.

K780811 · Cavitron Corp. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1978
Decision
35d
Days
Class 1
Risk

K780811 is an FDA 510(k) clearance for the DENTAL ABRASIVE DEVICE. Classified as Point, Abrasive (product code EHL), Class I - General Controls.

Submitted by Cavitron Corp. (Mchenry, US). The FDA issued a Cleared decision on June 22, 1978 after a review of 35 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6010 - 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 K780811 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 18, 1978
Decision Date June 22, 1978
Days to Decision 35 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
92d faster than avg
Panel avg: 127d · This submission: 35d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EHL Point, Abrasive
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.6010
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.