Cleared Traditional

K101617 - FLEXITIME XTREME 2 HEAVY TRAY CARTRIDGE REFILL, FEXITIME XTREME 2 LIGHT TRAY CARTRIDGE REFILL

K101617 is an FDA 510(k) clearance for FLEXITIME XTREME 2 HEAVY TRAY CARTRIDGE..., 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 90-day FDA review.

K101617 · Heraeus Kulzer, LLC · Dental device
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Sep 2010
Decision
90d
Days
Class 2
Risk

K101617 is an FDA 510(k) clearance for the FLEXITIME XTREME 2 HEAVY TRAY CARTRIDGE REFILL, FEXITIME XTREME 2 LIGHT TRAY .... 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 September 7, 2010 after a review of 90 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 Heraeus Kulzer, LLC devices

FDA 510(k) Submission Details - K101617

510(k) Number K101617 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 09, 2010
Decision Date September 07, 2010
Days to Decision 90 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
37d faster than avg
Panel avg: 127d · This submission: 90d
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 248
Devices cleared under the same product code (ELW) and FDA review panel - the closest regulatory comparables to K101617.
TAKE 1 ADVANCED RIGID TRAY
K110092 · Kerr Corporation · Apr 2011
FIT TEST C&B
K110050 · Voco GmbH · Mar 2011
VONFLEX HEAVY, VINFLEX LIGHT
K103164 · Vericom Co., Ltd. · Nov 2010
TAKE 1 ADVANCED RIGID TRAY
K092176 · Kerr Corporation · Jan 2010
FLEXITIME FLOW
K091494 · Heraeus Kulzer, Inc. · Jul 2009
VONFLEX PUTTY
K091267 · Vericom Co., Ltd. · May 2009