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) Official FDA 510(k) Summary (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.

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
118d faster than avg
Panel avg: 128d · 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 Consultant

Regulatory Technology Services, LLC
MARK JOB

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 - ELW Material, Impression

All 391
Devices cleared under the same product code (ELW) and FDA review panel - the closest regulatory comparables to K113263.
GC BLUE SILICONE
K120521 · GC America, Inc. · May 2012
FLASH (DIFFERENT MATERIALS)
K120438 · 3M Deutschland GmbH · May 2012
AQUASIL ULTRA SMART WETTING IMPRESSION MATERIAL
K113406 · Dentsply International, Inc. · Feb 2012
IDENTIUM HEAVY, IDENTIUM MEDIUM, IDENTIUM SCAN HEAVY, IDENTIUM SCAN MEDIUM, IDENTIUM SCAN LIGHT
K113279 · Kettenbach GmbH & Co. KG · Nov 2011
FIT CHECKER ADVANCED
K110871 · GC America, Inc. · Jun 2011
TAKE 1 ADVANCED RIGID TRAY
K110092 · Kerr Corporation · Apr 2011
K113263 · ARGES IMAGING CONTRAST SPRAY
Download PDF FDA Summary Arges Imaging, Inc.