Lotus Prophy Angle— 510(k) K220346

Name: FDA 510(k) clearance K220346
Creator: U.S. Food and Drug Administration
Published: 2022-11-07

Substantially Equivalent

Ajk Engineering, Inc.

FDA 510(k) clearance K220346 for Lotus Prophy Angle, Substantially Equivalent on 2022-11-07. Applicant: Ajk Engineering, Inc.. Device class: 1.

Clearance details

Applicant: Ajk Engineering, Inc.
Product code: Code EGS
Device class: Class 1
Regulation: 21 CFR 872.4200
Advisory panel: Dental
Date received: 2022-02-07
Decision date: 2022-11-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sommerville, SC, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code EGS

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K251869 — Disposable Prophy Angle (3399-60, 3399-090, 3399-105)2025-09-15
K240950 — Disposable Prophy Angle2025-05-28
K240183 — Star E900 Handpiece Series2024-09-19
K230106 — General Cutting Straight2023-05-24
K222518 — FX Contra2022-11-17

Adverse events under product code EGS

product code EGS

Injury: 356
Malfunction: 759
Total: 1,115

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.