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) Official FDA 510(k) Summary (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.

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
122d faster than avg
Panel avg: 128d · 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 64
Devices cleared under the same product code (EGS) and FDA review panel - the closest regulatory comparables to K051077.
EXCEL CONTRA ANGLE HANDPIECE
K061897 · Orthosource, Inc. · Feb 2007
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K060317 · Est. Anthogyr · Apr 2006
DR DISPOSABLE PROPHY ANGLE MODEL H310
K060377 · Dental Resources · Apr 2006
AX'S ENDO 04, 06, 08, 2.5, 40 , MODELS 50100206, 50100217, 50100218, 50100230, 50100232
K042171 · Micro-Mega Societe Anonyme · Nov 2004
B&R DEVICE
K032925 · Ronvig A/S · Dec 2003
CONTRA-ANGLE, MODELS 1059, 5050, 5051, 5055, 5056, 5057, 5059, 5060, 5061, 5062, 5063, 5064, 5065, 5066, 5067, 5068,
K022505 · NOUVAG AG · Oct 2003
K051077 · E-TYPE STRAIGHT HANDPIECE, MODEL AHP-101
Download PDF FDA Summary Aseptico, Inc.