Cleared Traditional

K042878 - FLEXITIME XTREME

K042878 is an FDA 510(k) clearance for FLEXITIME XTREME, manufactured by Heraeus Kulzer, Inc.. The device is a Class 2 Dental device with product code ELW cleared through the Traditional 510(k) pathway after a 60-day FDA review.

K042878 · Heraeus Kulzer, Inc. · Dental device
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Dec 2004
Decision
60d
Days
Class 2
Risk

K042878 is an FDA 510(k) clearance for the FLEXITIME XTREME. Classified as Material, Impression (product code ELW), Class II - Special Controls.

Submitted by Heraeus Kulzer, Inc. (South Bend, US). The FDA issued a Cleared decision on December 17, 2004 after a review of 60 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 Heraeus Kulzer, Inc. devices

FDA 510(k) Submission Details - K042878

510(k) Number K042878 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 18, 2004
Decision Date December 17, 2004
Days to Decision 60 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
67d faster than avg
Panel avg: 127d · This submission: 60d
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 325
Devices cleared under the same product code (ELW) and FDA review panel - the closest regulatory comparables to K042878.
RETRACTOFOAM
K050013 · Coltene/Whaledent AG · Feb 2005
FUSION FAST
K043471 · GC America, Inc. · Jan 2005
HYDROGUM SOFT
K043118 · Zhermack S.P.A. · Jan 2005
TORPICALGIN
K043131 · Zhermack S.P.A. · Dec 2004
CORRECT DENTAL IMPRESSION MATERIAL
K042860 · Handae Chemical Co., Ltd. · Dec 2004
GC FUSION
K041398 · GC America, Inc. · Jun 2004