Cleared Traditional

K051077 - E-TYPE STRAIGHT HANDPIECE, MODEL AHP-101

K051077 is an FDA 510(k) clearance for E-TYPE STRAIGHT HANDPIECE, 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 6-day FDA review.

K051077 · Aseptico, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2005
Decision
6d
Days
Class 1
Risk

K051077 is an FDA 510(k) clearance for the E-TYPE STRAIGHT HANDPIECE, MODEL AHP-101. 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 May 3, 2005 after a review of 6 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

FDA 510(k) Submission Details - K051077

510(k) Number K051077 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 27, 2005
Decision Date May 03, 2005
Days to Decision 6 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
121d faster than avg
Panel avg: 127d · This submission: 6d
Pathway characteristics
Predicate-based equivalence. Third-party reviewed.

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 Consultant

Intertek Testing Services
DANIEL W LEHTONEN

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - EGS Handpiece, Contra- And Right-angle Attachment, Dental

All 37
Devices cleared under the same product code (EGS) and FDA review panel - the closest regulatory comparables to K051077.
TORQTECH
K103697 · J. Morita USA, Inc. · Jan 2012
MONTBLANC SURGICAL CONTRA-ANGLE AND STRAIGHT HANDPIECE
K111532 · Anthogyr Sas · Oct 2011
STRONG DENTAL HANDPIECES
K100192 · Saeshin Precision Co., Ltd. · Feb 2010
AHP-66 4:1 REDUCTION CONTRANGLE: AHP-88 8:1 REDUCTION CONTRANGLE: AHP-88MP 8:1 REDUCTION CONTRANGLE - PUSH BUTTON
K020137 · Aseptico, Inc. · Mar 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