Cleared Abbreviated

VITIQUE SYSTEM (K023649) - FDA 510(k) Clearance

Class II Dental device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K023649 · Dmg USA, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2003
Decision
79d
Days
Class 2
Risk

K023649 is an FDA 510(k) clearance for the VITIQUE SYSTEM. Classified as Cement, Dental (product code EMA), Class II - Special Controls.

Submitted by Dmg USA, Inc. (Ayer, US). The FDA issued a Cleared decision on January 17, 2003 after a review of 79 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3275 - the FDA dental device regulatory framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Dmg USA, Inc. devices

Submission Details

510(k) Number K023649 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 30, 2002
Decision Date January 17, 2003
Days to Decision 79 days
Submission Type Abbreviated
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
48d faster than avg
Panel avg: 127d · This submission: 79d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code EMA Cement, Dental
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3275
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 - EMA Cement, Dental

All 80
Devices cleared under the same product code (EMA) and FDA review panel - the closest regulatory comparables to K023649.
DYRACT CEM PLUS CEMENT
K041272 · Dentsply Intl. · Oct 2004
CALIBRA CEMENT
K040906 · Dentsply Intl. · Jun 2004
INTEGRITY TEMPORARY CEMENT
K040895 · Dentsply Intl. · May 2004
RELYX RMGIP
K022476 · 3M Company · Aug 2002
GILB, MODEL 8010
K011200 · 3M Company · Jun 2001
DYRACT CEM LCI COMPOMER
K003921 · Dentsply Intl. · Jan 2001