Cleared Traditional

K060891 - VIRTUAL

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

K060891 · Ivoclar Vivadent, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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.

Device Classification

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 140
Devices cleared under the same product code (ELW) and FDA review panel - the closest regulatory comparables to K060891.
FIT TEST C&B
K110050 · Voco GmbH · Mar 2011
FLEXITIME FLOW
K091494 · Heraeus Kulzer, Inc. · Jul 2009
CEREC OPTI SPRAY
K080882 · Sirona Dental Systems GmbH · Apr 2008
PRE-IMPRESSION CONDITIONING SOLUTION
K061427 · Dentsply Intl. · Jun 2006
EXPASYL POWER APPLICATOR
K051933 · Sybron Dental Specialties, Inc. · Jan 2006
MODIFICATION TO:REGISTRADO X-TRA
K051535 · Voco GmbH · Jun 2005