Cleared Traditional

K113301 - CONCENPIECE

K113301 is the FDA 510(k) clearance for CONCENPIECE by Dentalez, Inc.. It is a Class 1 Dental device (product code EFB) cleared through the Traditional 510(k) pathway after a 76-day FDA review.

K113301 · Dentalez, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2012
Decision
76d
Days
Class 1
Risk

K113301 is an FDA 510(k) clearance for the CONCENPIECE,HIGH-SPEED HANDPIECE SERIES. Classified as Handpiece, Air-powered, Dental (product code EFB), Class I - General Controls.

Submitted by Dentalez, Inc. (Lancaster, US). The FDA issued a Cleared decision on January 23, 2012 after a review of 76 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 Dentalez, Inc. devices

Submission Details

510(k) Number K113301 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 08, 2011
Decision Date January 23, 2012
Days to Decision 76 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
51d faster than avg
Panel avg: 127d · This submission: 76d
Pathway characteristics
Predicate-based equivalence.

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 67
Devices cleared under the same product code (EFB) and FDA review panel - the closest regulatory comparables to K113301.
Dental High-speed Handpiece and Accessories
K173943 · Microp Technology (Taiwan), Inc. · Jul 2018
High-speed Turbine Handpieces for Single Use
K172543 · Beijing Dongbo Dental Handpiece Co., Ltd. · Jul 2018
Concentrix MX-AC High-Speed Handpiece
K173465 · Dentalez, Inc. · Mar 2018
BOSWORTH AIR POLISHER
K100731 · Harry J. Bosworth Co. · Dec 2010
CENTURY MODEL 105C
K093341 · Sybron Dental Specialties, Inc. · Apr 2010
AIR TORX, MODEL TRA-200, TRA-200-CP3, TRA-200-CP4
K091065 · J. Morita USA, Inc. · Oct 2009