Cleared Traditional

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

Class I Dental device.

K020137 · Aseptico, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2002
Decision
47d
Days
Class 1
Risk

K020137 is an FDA 510(k) clearance for the AHP-66 4:1 REDUCTION CONTRANGLE: AHP-88 8:1 REDUCTION CONTRANGLE: AHP-88MP 8:.... Classified as Handpiece, Contra- And Right-angle Attachment, Dental (product code EGS), Class I - General Controls.

Submitted by Aseptico, Inc. (Woodinville, US). The FDA issued a Cleared decision on March 4, 2002 after a review of 47 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Aseptico, Inc. devices

Submission Details

510(k) Number K020137 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 16, 2002
Decision Date March 04, 2002
Days to Decision 47 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
80d faster than avg
Panel avg: 127d · This submission: 47d
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 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 K020137.
Disposable Prophy Angle (3399-60, 3399-090, 3399-105)
K251869 · Premium Plus (Dongguan) Limited · Sep 2025
Disposable Prophy Angle
K240950 · Pacific Care Limited · May 2025
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
Lotus Prophy Angle
K220346 · Ajk Engineering, Inc. · Nov 2022