Cleared Traditional

K944719 - W&H 100 SERIES LOW SPEED

K944719 is the FDA 510(k) clearance for W&H 100 SERIES LOW SPEED by A-Dec, Inc.. It is a Class 1 Dental device (product code EFB) cleared through the Traditional 510(k) pathway after a 377-day FDA review.

K944719 · A-Dec, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1995
Decision
377d
Days
Class 1
Risk

K944719 is an FDA 510(k) clearance for the W&H 100 SERIES LOW SPEED. Classified as Handpiece, Air-powered, Dental (product code EFB), Class I - General Controls.

Submitted by A-Dec, Inc. (Newberg, US). The FDA issued a Cleared decision on October 5, 1995 after a review of 377 days - an unusually long review period, suggesting complex equivalence evaluation.

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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all A-Dec, Inc. devices

Submission Details

510(k) Number K944719 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 23, 1994
Decision Date October 05, 1995
Days to Decision 377 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
250d slower than avg
Panel avg: 127d · This submission: 377d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 77
Devices cleared under the same product code (EFB) and FDA review panel - the closest regulatory comparables to K944719.
SYNEA-HS HIGH SPEED-HANDPIECE
K992011 · A-Dec, Inc. · Sep 1999
MODEL MS-2 HANDPIECE
K982050 · Parkell, Inc. · Sep 1998
W&H 900 INCOLIGHT LT HANDPIECE
K944718 · A-Dec, Inc. · Oct 1995
W&H ROTO QUICK COUPLINGS
K945734 · A-Dec, Inc. · Oct 1995
W&H MICRO AIR MOTOR LT25
K944713 · A-Dec, Inc. · Aug 1995
W&H AIR MOTOR A25
K944711 · A-Dec, Inc. · Aug 1995