Cleared Abbreviated

K061897 - EXCEL CONTRA ANGLE HANDPIECE

K061897 is an FDA 510(k) clearance for EXCEL CONTRA ANGLE HANDPIECE, manufactured by Orthosource, Inc.. The device is a Class 1 Dental device with product code EGS cleared through the Abbreviated 510(k) pathway after a 226-day FDA review.

K061897 · Orthosource, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2007
Decision
226d
Days
Class 1
Risk

K061897 is an FDA 510(k) clearance for the EXCEL CONTRA ANGLE HANDPIECE. Classified as Handpiece, Contra- And Right-angle Attachment, Dental (product code EGS), Class I - General Controls.

Submitted by Orthosource, Inc. (North Hollywood, US). The FDA issued a Cleared decision on February 14, 2007 after a review of 226 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4200 - the FDA dental device regulatory framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

FDA 510(k) Submission Details - K061897

510(k) Number K061897 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 03, 2006
Decision Date February 14, 2007
Days to Decision 226 days
Submission Type Abbreviated
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
98d slower than avg
Panel avg: 128d · This submission: 226d
Pathway characteristics
Standards-based clearance path.

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 K061897.
PREMIUM PLUS DISPOSABLE PROPHY ANGLE MODEL 3399
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ANTHOGYR CONTRA ANGLES AND HANDPIECES
K060317 · Est. Anthogyr · Apr 2006
DR DISPOSABLE PROPHY ANGLE MODEL H310
K060377 · Dental Resources · Apr 2006
E-TYPE STRAIGHT HANDPIECE, MODEL AHP-101
K051077 · Aseptico, Inc. · May 2005
K061897 · EXCEL CONTRA ANGLE HANDPIECE
Download PDF Orthosource, Inc.