Cleared Abbreviated

K141221 - LARES ULTRALITE PROSTYLE HIGH-SPEED DEN...

K141221 is the FDA 510(k) clearance for LARES ULTRALITE PROSTYLE HIGH-SPEED DEN... by Lares Research, Inc.. It is a Class 1 Dental device (product code EFB) cleared through the Abbreviated 510(k) pathway after a 169-day FDA review.

K141221 · Lares Research, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2014
Decision
169d
Days
Class 1
Risk

K141221 is an FDA 510(k) clearance for the LARES ULTRALITE PROSTYLE HIGH-SPEED DENTAL HANDPIECES, LARES EURO PROSTYLE HI.... Classified as Handpiece, Air-powered, Dental (product code EFB), Class I - General Controls.

Submitted by Lares Research, Inc. (Chico, US). The FDA issued a Cleared decision on October 28, 2014 after a review of 169 days - an extended review cycle.

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 Lares Research, Inc. devices

Submission Details

510(k) Number K141221 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 12, 2014
Decision Date October 28, 2014
Days to Decision 169 days
Submission Type Abbreviated
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
42d slower than avg
Panel avg: 127d · This submission: 169d
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 59
Devices cleared under the same product code (EFB) and FDA review panel - the closest regulatory comparables to K141221.
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
CENTURY MODEL 105C
K093341 · Sybron Dental Specialties, Inc. · Apr 2010
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