Cleared Traditional

K220874 - Smooth Drive contra angle and straight ...

K220874 is an FDA 510(k) clearance for Smooth Drive contra angle and straight ..., manufactured by Lares Research. The device is a Class 1 Dental device with product code EGS cleared through the Traditional 510(k) pathway after a 227-day FDA review.

K220874 · Lares Research · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2022
Decision
227d
Days
Class 1
Risk

K220874 is an FDA 510(k) clearance for the Smooth Drive contra angle and straight handpieces. Classified as Handpiece, Contra- And Right-angle Attachment, Dental (product code EGS), Class I - General Controls.

Submitted by Lares Research (Chico, US). The FDA issued a Cleared decision on November 7, 2022 after a review of 227 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 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.

View all Lares Research devices

FDA 510(k) Submission Details - K220874

510(k) Number K220874 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 25, 2022
Decision Date November 07, 2022
Days to Decision 227 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
100d slower than avg
Panel avg: 127d · This submission: 227d
Pathway characteristics
Predicate-based equivalence.

EGS Device Classification - Class 1, General Controls

Product Code EGS Handpiece, Contra- And Right-angle Attachment, 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 - EGS Handpiece, Contra- And Right-angle Attachment, Dental

All 19
Devices cleared under the same product code (EGS) and FDA review panel - the closest regulatory comparables to K220874.
General Cutting Straight
K230106 · Nakanishi, Inc. · May 2023
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Dental Handpiece, Model CA160, CA160L, and CA500L
K220577 · Micro-Nx Co., Ltd. · Jul 2022
SURGmatic S15 L Pro
K213139 · Kavo Dental GmbH · Dec 2021
General Cutting Contra Handpiece
K202960 · Nakanishi, Inc. · Oct 2020