Cleared Traditional

K944716 - W&H 796 TOP AIR TURBINE MINI-HEAD

K944716 is an FDA 510(k) clearance for W&H 796 TOP AIR TURBINE MINI-HEAD, manufactured by A-Dec, Inc.. The device is a Class 1 Dental device with product code EFB cleared through the Traditional 510(k) pathway after a 252-day FDA review.

K944716 · A-Dec, Inc. · Dental device
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Jun 1995
Decision
252d
Days
Class 1
Risk

K944716 is an FDA 510(k) clearance for the W&H 796 TOP AIR TURBINE MINI-HEAD. 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 June 2, 1995 after a review of 252 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. 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

FDA 510(k) Submission Details - K944716

510(k) Number K944716 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 23, 1994
Decision Date June 02, 1995
Days to Decision 252 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
125d slower than avg
Panel avg: 127d · This submission: 252d
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 K944716.
W&H 895 TOP LIGH HIGHSPEED FIBEROPTIC SINGLE SPRAY
K944708 · A-Dec, Inc. · Jun 1995
W&H 898 TOP LIGHT HIGHSPEED
K944710 · A-Dec, Inc. · Jun 1995
W&H 795 TOP AIR TURBINE SINGLE SPRAY
K944715 · A-Dec, Inc. · Jun 1995
W&H 798 TOP AIR TURBINE TRIPLE SPRAY
K944717 · A-Dec, Inc. · Jun 1995
OSTEOMED IB DRILL
K911937 · Osteomed Corp. · Jun 1991
DISPOSA-SHIELD(TM) INFECTION CONTROL BARRIER
K900093 · Dentsply Intl. · Apr 1990