Cleared Traditional

VIVASENS (K030922) - FDA 510(k) Clearance

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K030922 · Ivoclar Vivadent, Inc. · Dental device
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Oct 2003
Decision
207d
Days
Class 2
Risk

K030922 is an FDA 510(k) clearance for the VIVASENS. Classified as Varnish, Cavity (product code LBH), Class II - Special Controls.

Submitted by Ivoclar Vivadent, Inc. (Amherst, US). The FDA issued a Cleared decision on October 17, 2003 after a review of 207 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3260 - 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 K030922 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 24, 2003
Decision Date October 17, 2003
Days to Decision 207 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
80d slower than avg
Panel avg: 127d · This submission: 207d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LBH Varnish, Cavity
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3260
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 - LBH Varnish, Cavity

All 136
Devices cleared under the same product code (LBH) and FDA review panel - the closest regulatory comparables to K030922.
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FluoroDose Varnish
K250714 · Centrix, Inc. · Nov 2025
Rennou™ Varnish (3% / Spearmint)
K243777 · Theodent, LLC · May 2025
ReminGel
K241489 · Inter-Med, Inc. · Jan 2025