Cleared Traditional

K112623 - AIRLIGHT DENTAL HANDPIECE

K112623 is an FDA 510(k) clearance for AIRLIGHT DENTAL HANDPIECE, manufactured by Beyes Dental Canada, Inc.. The device is a Class 1 Dental device with product code EFB cleared through the Traditional 510(k) pathway after a 99-day FDA review.

K112623 · Beyes Dental Canada, Inc. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2011
Decision
99d
Days
Class 1
Risk

K112623 is an FDA 510(k) clearance for the AIRLIGHT DENTAL HANDPIECE. Classified as Handpiece, Air-powered, Dental (product code EFB), Class I - General Controls.

Submitted by Beyes Dental Canada, Inc. (Dover, US). The FDA issued a Cleared decision on December 16, 2011 after a review of 99 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 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.

FDA 510(k) Submission Details - K112623

510(k) Number K112623 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 08, 2011
Decision Date December 16, 2011
Days to Decision 99 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
29d faster than avg
Panel avg: 128d · This submission: 99d
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 237
Devices cleared under the same product code (EFB) and FDA review panel - the closest regulatory comparables to K112623.
ORTHOSLENDERIZER
K111249 · Orthomatics, Inc. · Feb 2012
PROPHY-MATE NEO
K112673 · Nakanishi, Inc. · Feb 2012
CONCENPIECE,HIGH-SPEED HANDPIECE SERIES
K113301 · Dentalez, Inc. · Jan 2012
EASYPROPHY SERIES AIR POLISH DEVICES, MODELS EASYPROPHY 200 AND EASYPROPHY 400
K112869 · Beyes Dental Canada, Inc. · Dec 2011
AIR-N-GO
K110379 · Satelec · Dec 2011
TIGER 500 SERIES HIGH SPEED HANDPIECES AND ATTACHMENTS
K102517 · Thunder Tiger Corp. · Apr 2011
K112623 · AIRLIGHT DENTAL HANDPIECE
Download PDF FDA Summary Beyes Dental Canada, …