Cleared Traditional

K905620 - MODIFIED SITE PERISTALTIC FOOTSWITCH

K905620 is an FDA 510(k) clearance for MODIFIED SITE PERISTALTIC FOOTSWITCH, manufactured by Site Microsurgical Systems, Inc.. The device is a Class 1 Dental device with product code EBW cleared through the Traditional 510(k) pathway after a 75-day FDA review.

K905620 · Site Microsurgical Systems, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1991
Decision
75d
Days
Class 1
Risk

K905620 is an FDA 510(k) clearance for the MODIFIED SITE PERISTALTIC FOOTSWITCH. Classified as Controller, Foot, Handpiece And Cord (product code EBW), Class I - General Controls.

Submitted by Site Microsurgical Systems, Inc. (Horsham, US). The FDA issued a Cleared decision on February 27, 1991 after a review of 75 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 Site Microsurgical Systems, Inc. devices

FDA 510(k) Submission Details - K905620

510(k) Number K905620 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 14, 1990
Decision Date February 27, 1991
Days to Decision 75 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
52d faster than avg
Panel avg: 127d · This submission: 75d
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 50
Devices cleared under the same product code (EBW) and FDA review panel - the closest regulatory comparables to K905620.
SURGIC II IMPLANT CONTROL UNIT
K972924 · Nsk Nakanishi, Inc. · Oct 1997
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
OPTIONAL ACCESSORY FOOT SWITCH MODEL 100
K790322 · Applied Medical Research · May 1979