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) Official FDA 510(k) Summary (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.

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
65d faster than avg
Panel avg: 128d · 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 Consultant

Intertek Testing Services
PAULA WILKERSON

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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 K101717.
TIGER 500 SERIES HIGH SPEED HANDPIECES AND ATTACHMENTS
K102517 · Thunder Tiger Corp. · Apr 2011
BOSWORTH AIR POLISHER
K100731 · Harry J. Bosworth Co. · Dec 2010
PACEMAKER HIGH-SPEED HANDPIECE MODEL PM-MQ, PM-M
K101551 · Delma Medical Instrument (Guangzhou) Co., Ltd. · Sep 2010
HHC PUSH-BUTTON REPLACEMENT TURBINE FOR MIDWEST TRADITION HANDPIECE MODEL MW TURBINE REPLACEMENT
K100389 · Handpiece Headquarters · Aug 2010
SYLE SMARTIP
K100833 · Osspray, Ltd. · Jun 2010
DENTAL HANDPIECE
K093971 · North West Medical Instrument (Group) Co., Ltd. · Apr 2010
K101717 · DENTAL HANDPIECES, MODELS: KARAM STD/MINI
Download PDF FDA Summary Aerobine, Inc.