Cleared Traditional

K964863 - MODEL 45E HANDENGINE & CONTROLLER, MODEL 45EH HANDENGINE & CONTROLLER, MODEL RX-100 HANDENGINE & CONTROLLER, MODEL ETELN

K964863 is an FDA 510(k) clearance for MODEL 45E HANDENGINE & 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 86-day FDA review.

K964863 · Bell Intl., Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1997
Decision
86d
Days
Class 1
Risk

K964863 is an FDA 510(k) clearance for the MODEL 45E HANDENGINE & CONTROLLER, MODEL 45EH HANDENGINE & CONTROLLER, MODEL .... 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 February 28, 1997 after a review of 86 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 - K964863

510(k) Number K964863 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 04, 1996
Decision Date February 28, 1997
Days to Decision 86 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
41d faster than avg
Panel avg: 127d · This submission: 86d
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 K964863.
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
MARK 20 AND MARK 25 HAND ENGINE CONTROLLER
K964860 · Bell Intl., Inc. · Mar 1997
MODIFIED SITE PERISTALTIC FOOTSWITCH
K905620 · Site Microsurgical Systems, Inc. · Feb 1991
OPTIONAL ACCESSORY FOOT SWITCH MODEL 100
K790322 · Applied Medical Research · May 1979