Cleared Traditional

K790322 - OPTIONAL ACCESSORY FOOT SWITCH MODEL 100

K790322 is an FDA 510(k) clearance for OPTIONAL ACCESSORY FOOT SWITCH MODEL 100, manufactured by Applied Medical Research. The device is a Class 1 Dental device with product code EBW cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K790322 · Applied Medical Research · Dental device
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May 1979
Decision
88d
Days
Class 1
Risk

K790322 is an FDA 510(k) clearance for the OPTIONAL ACCESSORY FOOT SWITCH MODEL 100. Classified as Controller, Foot, Handpiece And Cord (product code EBW), Class I - General Controls.

Submitted by Applied Medical Research (Mchenry, US). The FDA issued a Cleared decision on May 14, 1979 after a review of 88 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4200 - 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 Applied Medical Research devices

FDA 510(k) Submission Details - K790322

510(k) Number K790322 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 15, 1979
Decision Date May 14, 1979
Days to Decision 88 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
39d faster than avg
Panel avg: 127d · This submission: 88d
Pathway characteristics
Predicate-based equivalence.

EBW Device Classification - Class 1, General Controls

Product Code EBW Controller, Foot, Handpiece And Cord
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.4200
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.

Regulatory Peers - EBW Controller, Foot, Handpiece And Cord

All 54
Devices cleared under the same product code (EBW) and FDA review panel - the closest regulatory comparables to K790322.
MARK 20 AND MARK 25 HAND ENGINE CONTROLLER
K964860 · Bell Intl., Inc. · Mar 1997
MODEL 45E HANDENGINE & CONTROLLER, MODEL 45EH HANDENGINE & CONTROLLER, MODEL RX-100 HANDENGINE & CONTROLLER, MODEL ETELN
K964863 · Bell Intl., Inc. · Feb 1997
MODIFIED SITE PERISTALTIC FOOTSWITCH
K905620 · Site Microsurgical Systems, Inc. · Feb 1991