Cleared Traditional

K113263 - ARGES IMAGING CONTRAST SPRAY

K113263 is an FDA 510(k) clearance for ARGES IMAGING CONTRAST SPRAY, manufactured by Arges Imaging, Inc.. The device is a Class 2 Dental device with product code ELW cleared through the Traditional 510(k) pathway after a 10-day FDA review.

K113263 · Arges Imaging, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2011
Decision
10d
Days
Class 2
Risk

K113263 is an FDA 510(k) clearance for the ARGES IMAGING CONTRAST SPRAY. Classified as Material, Impression (product code ELW), Class II - Special Controls.

Submitted by Arges Imaging, Inc. (Pasadena, US). The FDA issued a Cleared decision on November 14, 2011 after a review of 10 days - a notably fast clearance cycle.

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: 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 Arges Imaging, Inc. devices

FDA 510(k) Submission Details - K113263

510(k) Number K113263 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 04, 2011
Decision Date November 14, 2011
Days to Decision 10 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
117d faster than avg
Panel avg: 127d · This submission: 10d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 257
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