Cleared Traditional

K963664 - DENTAL HANDPIECE AND ACCESSORY

K963664 is an FDA 510(k) clearance for DENTAL HANDPIECE AND ACCESSORY, manufactured by Filmtech, Inc.. The device is a Class 1 Dental device with product code EFB cleared through the Traditional 510(k) pathway after a 41-day FDA review.

K963664 · Filmtech, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1996
Decision
41d
Days
Class 1
Risk

K963664 is an FDA 510(k) clearance for the DENTAL HANDPIECE AND ACCESSORY. Classified as Handpiece, Air-powered, Dental (product code EFB), Class I - General Controls.

Submitted by Filmtech, Inc. (Brooklyn, US). The FDA issued a Cleared decision on October 24, 1996 after a review of 41 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 Filmtech, Inc. devices

FDA 510(k) Submission Details - K963664

510(k) Number K963664 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 13, 1996
Decision Date October 24, 1996
Days to Decision 41 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
86d faster than avg
Panel avg: 127d · This submission: 41d
Pathway characteristics
Predicate-based equivalence.

EFB Device Classification - Class 1, General Controls

Product Code EFB Handpiece, Air-powered, Dental
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 - EFB Handpiece, Air-powered, Dental

All 162
Devices cleared under the same product code (EFB) and FDA review panel - the closest regulatory comparables to K963664.
ELECTRIC SURGICAL IRRIGATION SYSTEM - DUAL CONTROLLER UNIT
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SIRIUS 180, 180L, 230, 230L
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MIDWEST 300 SE
K962877 · Midwest Dental Products Corp. · Oct 1996
TRADITION P, PUSH BUTTON HANDPIECE
K963050 · Midwest Dental Products Corp. · Oct 1996
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K962542 · Nsk Nakanishi, Inc. · Sep 1996