Cleared Traditional

HOWMEDICA BRASS CENTER DISC (K790640) - FDA 510(k) Clearance

Class I Dental device.

K790640 · E.C. Moore Co. · Dental device
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May 1979
Decision
32d
Days
Class 1
Risk

K790640 is an FDA 510(k) clearance for the HOWMEDICA BRASS CENTER DISC. Classified as Disk, Abrasive (product code EHJ), Class I - General Controls.

Submitted by E.C. Moore Co. (Walker, US). The FDA issued a Cleared decision on May 1, 1979 after a review of 32 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 E.C. Moore Co. devices

Submission Details

510(k) Number K790640 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 30, 1979
Decision Date May 01, 1979
Days to Decision 32 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
95d faster than avg
Panel avg: 127d · This submission: 32d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EHJ Disk, 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.