Cleared Abbreviated

K070663 - A-DEC/W&H SYNEA AIR-DRIVEN HIGHSPEED HA...

K070663 is the FDA 510(k) clearance for A-DEC/W&H SYNEA AIR-DRIVEN HIGHSPEED HA... by A-Dec, Inc.. It is a Class 1 Dental device (product code EFB) cleared through the Abbreviated 510(k) pathway after a 118-day FDA review.

K070663 · A-Dec, Inc. · Dental device
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Optimized for regulatory review, auditing and printing
Jul 2007
Decision
118d
Days
Class 1
Risk

K070663 is an FDA 510(k) clearance for the A-DEC/W&H SYNEA AIR-DRIVEN HIGHSPEED HANDPIECE, MODEL TA-98, TA-97, A-DEC/W&.... 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 July 5, 2007 after a review of 118 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4200 - the FDA dental device regulatory framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all A-Dec, Inc. devices

Submission Details

510(k) Number K070663 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 09, 2007
Decision Date July 05, 2007
Days to Decision 118 days
Submission Type Abbreviated
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
9d faster than avg
Panel avg: 127d · This submission: 118d
Pathway characteristics
Standards-based clearance path.

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 K070663.
A-DEC/W&H ALEGRA AIR-DRIVEN HIGHSPEED HANDPIECE, MODEL TE-97, TE-98, A-DEC/W&H ALEGRA HANDPIECE ATTACHMENT, MODEL HE-43
K082716 · A-Dec, Inc. · Jan 2009
A-DEC/W&H PROFIN RECIPROCATING CONTRA-ANGLE HANDPIECE ATTACHMENT
K082827 · A-Dec, Inc. · Jan 2009
SUPERTORQUE HIGH-SPEED HANDPIECES AND GENTLEPOWER HANDPIECES AND ATTACHEMENTS
K073478 · Sybron Dental Specialties, Inc. · Sep 2008
LUBRINA, MODEL HIM-1
K070074 · J. Morita USA, Inc. · May 2007
AIR SOLFY, MODELS AS-4H, AS-4H-O, AS-4H-V, AS-4H-OV, AS-1,AS-1-0,AS-1-V, AS-1-OV
K043497 · J. Morita USA, Inc. · Mar 2005
TWIN POWER TURBINE HIGH SPEED AIR TURBINE DENTAL HANDPIECE
K043498 · J. Morita USA, Inc. · Feb 2005