Cleared Traditional

K060891 - VIRTUAL

K060891 is an FDA 510(k) clearance for VIRTUAL, manufactured by Ivoclar Vivadent, Inc.. The device is a Class 2 Dental device with product code ELW cleared through the Traditional 510(k) pathway after a 108-day FDA review.

K060891 · Ivoclar Vivadent, Inc. · Dental device
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Jul 2006
Decision
108d
Days
Class 2
Risk

K060891 is an FDA 510(k) clearance for the VIRTUAL. Classified as Material, Impression (product code ELW), Class II - Special Controls.

Submitted by Ivoclar Vivadent, Inc. (Amherst, US). The FDA issued a Cleared decision on July 17, 2006 after a review of 108 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 Ivoclar Vivadent, Inc. devices

FDA 510(k) Submission Details - K060891

510(k) Number K060891 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 2006
Decision Date July 17, 2006
Days to Decision 108 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
19d faster than avg
Panel avg: 127d · This submission: 108d
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 308
Devices cleared under the same product code (ELW) and FDA review panel - the closest regulatory comparables to K060891.
COLORISE
K070677 · Zhermack S.P.A. · May 2007
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K070700 · Zhermack S.P.A. · Apr 2007
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K062400 · Cavex Holland BV · Nov 2006
SIMULATE, COLOR CHANGE ALGINATE
K061267 · Cavex Holland BV · Jul 2006
PRE-IMPRESSION CONDITIONING SOLUTION
K061427 · Dentsply Intl. · Jun 2006
COLORBITE
K053619 · Zhermack S.P.A. · Mar 2006