Cleared Traditional

EGS MODEL 100-2 (K832370) - FDA 510(k) Clearance

K832370 · Electro-Med Health Industries, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1983
Decision
60d
Days
-
Risk

K832370 is an FDA 510(k) clearance for the EGS MODEL 100-2.

Submitted by Electro-Med Health Industries, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 16, 1983 after a review of 60 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel. 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 Electro-Med Health Industries, Inc. devices

Submission Details

510(k) Number K832370 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 18, 1983
Decision Date September 16, 1983
Days to Decision 60 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
67d faster than avg
Panel avg: 127d · This submission: 60d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -