Cleared Traditional

K020137 - AHP-66 4:1 REDUCTION CONTRANGLE: AHP-88 8:1 REDUCTION CONTRANGLE: AHP-88MP 8:1 REDUCTION CONTRANGLE - PUSH BUTTON

K020137 is an FDA 510(k) clearance for AHP-66 4:1 REDUCTION CONTRANGLE: AHP-88..., manufactured by Aseptico, Inc.. The device is a Class 1 Dental device with product code EGS cleared through the Traditional 510(k) pathway after a 47-day FDA review.

K020137 · Aseptico, Inc. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (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.

FDA 510(k) Submission Details - K020137

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
81d faster than avg
Panel avg: 128d · This submission: 47d
Pathway characteristics
Predicate-based equivalence.

EGS Device Classification - Class 1, General Controls

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 64
Devices cleared under the same product code (EGS) and FDA review panel - the closest regulatory comparables to K020137.
PROANGLE DISPOSABLE PROPHY ANGLE
K030603 · Pac-Dent International (Suzhou), Ltd. · Apr 2003
ST. GEORGE TECHNOLOGY, INC PERFECTION PLUS DISPOSABLE PROPHY ANGLE
K023953 · St. George Technology, Inc. · Feb 2003
CLEAN 'N' OIL
K022264 · Svenska Dental Instruments AB · Oct 2002
SURGICAL CONTRA-ANGEL HANDPIECES TYPES WS-56E,WS-75E/KM,WS-92 E/3,SURGICAL STRAIGHT HANDPIECES TYPES, S-9, S-10, S-11
K011061 · W&H Dentalwerk Buermoos GmbH · Jun 2001
EXTENDED STRAIGHT ATTACHMENT
K994024 · Team Technologies, Inc. · Feb 2000
STARDENTAL TITAN 3 LUBEFREE MOTOR ATTACHMENTS
K983574 · Dentalez Group · Jan 1999
K020137 · AHP-66 4:1 REDUCTION CONTRANGLE: AHP-88 8:1 REDUCTION CONTRANGLE: AHP-88MP 8:1 REDUCTION CONTRANGLE - PUSH BUTTON
Download PDF FDA Summary Aseptico, Inc.