Cleared Traditional

K220346 - Lotus Prophy Angle (FDA 510(k) Clearance)

Class I Dental device.

K220346 · Ajk Engineering, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2022
Decision
273d
Days
Class 1
Risk

K220346 is an FDA 510(k) clearance for the Lotus Prophy Angle. Classified as Handpiece, Contra- And Right-angle Attachment, Dental (product code EGS), Class I - General Controls.

Submitted by Ajk Engineering, Inc. (Sommerville, US). The FDA issued a Cleared decision on November 7, 2022 after a review of 273 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 Ajk Engineering, Inc. devices

Submission Details

510(k) Number K220346 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 07, 2022
Decision Date November 07, 2022
Days to Decision 273 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
146d slower than avg
Panel avg: 127d · This submission: 273d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 Consultant

MRC Global, LLC
Christine Scifert

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

All 72
Devices cleared under the same product code (EGS) and FDA review panel - the closest regulatory comparables to K220346.
Disposable Prophy Angle (3399-60, 3399-090, 3399-105)
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Star E900 Handpiece Series
K240183 · Dentalez, Inc., Stardental Division · Sep 2024
General Cutting Straight
K230106 · Nakanishi, Inc. · May 2023
FX Contra
K222518 · Nakanishi, Inc. · Nov 2022
Smooth Drive contra angle and straight handpieces
K220874 · Lares Research · Nov 2022