RITE-ANGLE DISPOSABLE PROPHY ANGLES— 510(k) K954802

Name: FDA 510(k) clearance K954802
Creator: U.S. Food and Drug Administration
Published: 1995-11-08

Substantially Equivalent

Ash-USA

FDA 510(k) clearance K954802 for RITE-ANGLE DISPOSABLE PROPHY ANGLES, Substantially Equivalent on 1995-11-08. Applicant: Ash-USA. Device class: 1.

Clearance details

Applicant: Ash-USA
Product code: Code EGS
Device class: Class 1
Regulation: 21 CFR 872.4200
Advisory panel: Dental
Date received: 1995-10-19
Decision date: 1995-11-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: York, PA, 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.