Cleared Traditional

K964860 - MARK 20 AND MARK 25 HAND ENGINE CONTROLLER

K964860 is an FDA 510(k) clearance for MARK 20 AND MARK 25 HAND ENGINE CONTROLLER, manufactured by Bell Intl., Inc.. The device is a Class 1 Dental device with product code EBW cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K964860 · Bell Intl., Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1997
Decision
89d
Days
Class 1
Risk

K964860 is an FDA 510(k) clearance for the MARK 20 AND MARK 25 HAND ENGINE CONTROLLER. Classified as Controller, Foot, Handpiece And Cord (product code EBW), Class I - General Controls.

Submitted by Bell Intl., Inc. (Burlingame, US). The FDA issued a Cleared decision on March 3, 1997 after a review of 89 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 Bell Intl., Inc. devices

FDA 510(k) Submission Details - K964860

510(k) Number K964860 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 04, 1996
Decision Date March 03, 1997
Days to Decision 89 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
38d faster than avg
Panel avg: 127d · This submission: 89d
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 41
Devices cleared under the same product code (EBW) and FDA review panel - the closest regulatory comparables to K964860.
ROTARY MASTER
K992648 · J. Morita USA, Inc. · Jan 2000
ELCOMED 100 TYPES 9925 (W&H- AND INNOVA-VERSION) AND 9927 (ASTRA-VERSION), ELCOMED 200 TYPE 9926 (W&H-VERSION)
K972889 · W & H Dentalwerk · Jan 1998
SURGIC II IMPLANT CONTROL UNIT
K972924 · Nsk Nakanishi, Inc. · Oct 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
OPTIONAL ACCESSORY FOOT SWITCH MODEL 100
K790322 · Applied Medical Research · May 1979