Cleared Traditional

K113574 - FLEXITIME MONOPHASE PRO SCAN

K113574 is an FDA 510(k) clearance for FLEXITIME MONOPHASE PRO SCAN, manufactured by Heraeus Kulzer, LLC. The device is a Class 2 Dental device with product code ELW cleared through the Traditional 510(k) pathway after a 224-day FDA review.

K113574 · Heraeus Kulzer, LLC · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2012
Decision
224d
Days
Class 2
Risk

K113574 is an FDA 510(k) clearance for the FLEXITIME MONOPHASE PRO SCAN. Classified as Material, Impression (product code ELW), Class II - Special Controls.

Submitted by Heraeus Kulzer, LLC (South Bend, US). The FDA issued a Cleared decision on July 13, 2012 after a review of 224 days - an extended review 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: 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.

FDA 510(k) Submission Details - K113574

510(k) Number K113574 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 02, 2011
Decision Date July 13, 2012
Days to Decision 224 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
96d slower than avg
Panel avg: 128d · This submission: 224d
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 364
Devices cleared under the same product code (ELW) and FDA review panel - the closest regulatory comparables to K113574.
XANTASIL DYNAMIX FAST SET CARTRIDGE -2 X 380ML
K130647 · Heraeus Kulzer, LLC · May 2013
ALGINOR ALGINELLE TYPE 1 AND 2 MILLENIUM KROMOPAN 1 AND 2
K121824 · Lascod Spa · Aug 2012
FLEXITIME FAST & SCAN LIGHT FLOW
K120914 · Heraeus Kulzer, LLC · Jul 2012
TEMPSPAN CLEAR MATRIX
K120013 · Pentron Clinical · May 2012
GC BLUE SILICONE
K120521 · GC America, Inc. · May 2012
FLASH (DIFFERENT MATERIALS)
K120438 · 3M Deutschland GmbH · May 2012