Cleared Abbreviated

K061581 - EXCEL HIGH SPEED DENTAL HANDPIECE

K061581 is an FDA 510(k) clearance for EXCEL HIGH SPEED DENTAL HANDPIECE, manufactured by Orthosource, Inc.. The device is a Class 1 Dental device with product code EFA cleared through the Abbreviated 510(k) pathway after a 70-day FDA review.

K061581 · Orthosource, Inc. · Dental device
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Aug 2006
Decision
70d
Days
Class 1
Risk

K061581 is an FDA 510(k) clearance for the EXCEL HIGH SPEED DENTAL HANDPIECE. Classified as Handpiece, Belt And/or Gear Driven, Dental (product code EFA), Class I - General Controls.

Submitted by Orthosource, Inc. (North Hollywood, US). The FDA issued a Cleared decision on August 16, 2006 after a review of 70 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 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.

View all Orthosource, Inc. devices

FDA 510(k) Submission Details - K061581

510(k) Number K061581 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 07, 2006
Decision Date August 16, 2006
Days to Decision 70 days
Submission Type Abbreviated
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
57d faster than avg
Panel avg: 127d · This submission: 70d
Pathway characteristics
Standards-based clearance path.

EFA Device Classification - Class 1, General Controls

Product Code EFA Handpiece, Belt And/or Gear Driven, 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 - EFA Handpiece, Belt And/or Gear Driven, Dental

All 11
Devices cleared under the same product code (EFA) and FDA review panel - the closest regulatory comparables to K061581.
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