Cleared Traditional

K101717 - DENTAL HANDPIECES, MODELS: KARAM STD/MINI

Also marketed or referenced as:
BREEZE STD/MINI: KARAM 45 DEXOR 45 KARAM 4H COUPLING

K101717 is an FDA 510(k) clearance for DENTAL HANDPIECES, manufactured by Aerobine, Inc.. The device is a Class 1 Dental device with product code EFB cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K101717 · Aerobine, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2010
Decision
63d
Days
Class 1
Risk

K101717 is an FDA 510(k) clearance for the DENTAL HANDPIECES, MODELS: KARAM STD/MINI. Classified as Handpiece, Air-powered, Dental (product code EFB), Class I - General Controls.

Submitted by Aerobine, Inc. (San Diego, US). The FDA issued a Cleared decision on August 20, 2010 after a review of 63 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 Aerobine, Inc. devices

FDA 510(k) Submission Details - K101717

510(k) Number K101717 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 18, 2010
Decision Date August 20, 2010
Days to Decision 63 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
64d faster than avg
Panel avg: 127d · This submission: 63d
Pathway characteristics
Predicate-based equivalence. Third-party reviewed.

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 107
Devices cleared under the same product code (EFB) and FDA review panel - the closest regulatory comparables to K101717.
PROPHY-MATE NEO
K112673 · Nakanishi, Inc. · Feb 2012
AIR-N-GO
K110379 · Satelec · Dec 2011
BOSWORTH AIR POLISHER
K100731 · Harry J. Bosworth Co. · Dec 2010
CENTURY MODEL 105C
K093341 · Sybron Dental Specialties, Inc. · Apr 2010
EMS AIR-FLOW HANDY PERIO
K092289 · E.M.S Electro Medical Systems S.A · Oct 2009
AIR TORX, MODEL TRA-200, TRA-200-CP3, TRA-200-CP4
K091065 · J. Morita USA, Inc. · Oct 2009