AHP-66 4:1 REDUCTION CONTRANGLE: AHP-88 8:1 REDUCTION CONTRANGLE: AHP-88MP 8:1 REDUCTION CONTRANGLE - PUSH BUTTON— 510(k) K020137

Name: FDA 510(k) clearance K020137
Creator: U.S. Food and Drug Administration
Published: 2002-03-04

Substantially Equivalent

Aseptico, Inc.

FDA 510(k) clearance K020137 for AHP-66 4:1 REDUCTION CONTRANGLE: AHP-88 8:1 REDUCTION CONTRANGLE: AHP-88MP 8:1 REDUCTION CONTRANGLE - PUSH BUTTON, Substantially Equivalent on 2002-03-04. Applicant: Aseptico, Inc.. Device class: 1.

Clearance details

Applicant: Aseptico, Inc.
Product code: Code EGS
Device class: Class 1
Regulation: 21 CFR 872.4200
Advisory panel: Dental
Date received: 2002-01-16
Decision date: 2002-03-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Woodinville, WA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code EGS

view all

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

More clearances from Aseptico, Inc.

view all

K150129 — AEU-7000L-70V IMPLANT/ENDODONTIC DENTAL SYSTEM (LIGHTED VERSION)2015-05-28
K142124 — AEU-6000 IMPLANT / ENDODONTIC DENTAL SYSTEM2014-12-31
K130693 — AEU-525 TRANSPORT III PORTABLE DENTAL SYSTEM2013-08-14
K111078 — AEU-26L ELCTRONIC ENDODONTIC SYSTEM2011-06-14
K101332 — AMC-20 PORTABLE DENTAL CART MODEL AMC-202011-04-11

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.