Cleared Traditional

Perceptive electric dental motor and control unit (K220873) - FDA 510(k) Clearance

Class I Dental device.

K220873 · Lares Research · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2022
Decision
265d
Days
Class 1
Risk

K220873 is an FDA 510(k) clearance for the Perceptive electric dental motor and control unit. Classified as Unit, Operative Dental (product code EIA), Class I - General Controls.

Submitted by Lares Research (Chico, US). The FDA issued a Cleared decision on December 15, 2022 after a review of 265 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6640 - 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

Submission Details

510(k) Number K220873 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 25, 2022
Decision Date December 15, 2022
Days to Decision 265 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
138d slower than avg
Panel avg: 127d · This submission: 265d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EIA Unit, Operative Dental
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.6640
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 - EIA Unit, Operative Dental

All 24
Devices cleared under the same product code (EIA) and FDA review panel - the closest regulatory comparables to K220873.
ELEC Master, ELEC Master Dual
K202963 · Mgnewton , Ltd. · May 2023
N2
K211556 · Megagen Implant Co., Ltd. · Apr 2023
G7, Dental Operative Unit and Accessories
K213749 · Shinhung Company, Ltd. · Apr 2023
Infinity Pro, Logic, Quality, Sprint
K213742 · Olsen Ind?stria E Com?rcio S.A. · Oct 2022
A-dec 300, A-dec 500
K213932 · A-Dec, Inc. · Mar 2022
Infinity / Infinity Cross Flex Dental Systems
K180935 · Olsen Industria E Comercio S.A. · Feb 2020