Cleared Traditional

K103586 - IOS FASTSCAN SPRAY

K103586 is an FDA 510(k) clearance for IOS FASTSCAN SPRAY, manufactured by Ios Technnologies, Inc.. The device is a Class 2 Dental device with product code ELW cleared through the Traditional 510(k) pathway after a 113-day FDA review.

K103586 · Ios Technnologies, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2011
Decision
113d
Days
Class 2
Risk

K103586 is an FDA 510(k) clearance for the IOS FASTSCAN SPRAY. Classified as Material, Impression (product code ELW), Class II - Special Controls.

Submitted by Ios Technnologies, Inc. (San Diego, US). The FDA issued a Cleared decision on March 30, 2011 after a review of 113 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3660 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Ios Technnologies, Inc. devices

FDA 510(k) Submission Details - K103586

510(k) Number K103586 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 07, 2010
Decision Date March 30, 2011
Days to Decision 113 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
14d faster than avg
Panel avg: 127d · This submission: 113d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ELW Device Classification - Class 2, Special Controls

Product Code ELW Material, Impression
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3660
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - ELW Material, Impression

All 262
Devices cleared under the same product code (ELW) and FDA review panel - the closest regulatory comparables to K103586.
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