Cleared Traditional

K050013 - RETRACTOFOAM

K050013 is an FDA 510(k) clearance for RETRACTOFOAM, manufactured by Coltene/Whaledent AG. The device is a Class 2 Dental device with product code ELW cleared through the Traditional 510(k) pathway after a 37-day FDA review.

K050013 · Coltene/Whaledent AG · Dental device
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Feb 2005
Decision
37d
Days
Class 2
Risk

K050013 is an FDA 510(k) clearance for the RETRACTOFOAM. Classified as Material, Impression (product code ELW), Class II - Special Controls.

Submitted by Coltene/Whaledent AG (New York, US). The FDA issued a Cleared decision on February 9, 2005 after a review of 37 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 Coltene/Whaledent AG devices

FDA 510(k) Submission Details - K050013

510(k) Number K050013 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 03, 2005
Decision Date February 09, 2005
Days to Decision 37 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
90d faster than avg
Panel avg: 127d · This submission: 37d
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 306
Devices cleared under the same product code (ELW) and FDA review panel - the closest regulatory comparables to K050013.
KERR VPS IMPRESSION MATERIAL
K050604 · Sybron Dental Specialties, Inc. · Apr 2005
FUSION PUTTY TYPE
K043493 · GC America, Inc. · Mar 2005
GENIE MAGIC MIX ULTRA HYDROPHILIC IMPRESSION MATERIAL
K043054 · Sultan Chemists, Inc. · Feb 2005
FUSION FAST
K043471 · GC America, Inc. · Jan 2005
HYDROGUM SOFT
K043118 · Zhermack S.P.A. · Jan 2005
FLEXITIME XTREME
K042878 · Heraeus Kulzer, Inc. · Dec 2004