Cleared Traditional

K030922 - VIVASENS

K030922 is an FDA 510(k) clearance for VIVASENS, manufactured by Ivoclar Vivadent, Inc.. The device is a Class 2 Dental device with product code LBH cleared through the Traditional 510(k) pathway after a 207-day FDA review.

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

FDA 510(k) Submission Details - K030922

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
Combination Product No
PCCP Authorized No
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.

LBH Device Classification - Class 2, Special Controls

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 101
Devices cleared under the same product code (LBH) and FDA review panel - the closest regulatory comparables to K030922.
MULTIPLE (TOOTH DESENSITIZER)
K052263 · Cosmedent, Inc. · Dec 2005
FLOR-OPAL VARNISH, MODELS UP 4500/ UP 4501/ UP 4502
K051750 · Ultradent Products, Inc. · Sep 2005
PROTECT TOOTH DESENSITIZER
K050486 · Sunstar Butler · Jun 2005
FLUORIDE VARNISH
K031932 · Dentsply Intl. · Sep 2003
CHLORAPREP
K021131 · Centrix, Inc. · Sep 2002
SEAL & PROTECT PROTECTIVE SEALANT
K021805 · Dentsply Intl. · Aug 2002