Cleared Traditional

K082594 - REMESENSE

K082594 is an FDA 510(k) clearance for REMESENSE, manufactured by Remedent NV. The device is a Class 2 Dental device with product code LBH cleared through the Traditional 510(k) pathway after a 192-day FDA review.

K082594 · Remedent NV · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2009
Decision
192d
Days
Class 2
Risk

K082594 is an FDA 510(k) clearance for the REMESENSE. Classified as Varnish, Cavity (product code LBH), Class II - Special Controls.

Submitted by Remedent NV (Claremont, US). The FDA issued a Cleared decision on March 19, 2009 after a review of 192 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 Remedent NV devices

FDA 510(k) Submission Details - K082594

510(k) Number K082594 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 08, 2008
Decision Date March 19, 2009
Days to Decision 192 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
65d slower than avg
Panel avg: 127d · This submission: 192d
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 86
Devices cleared under the same product code (LBH) and FDA review panel - the closest regulatory comparables to K082594.
PULPDENT COPAL VARNISH WITH FLUORIDE
K100503 · Pulpdent Corporation · May 2010
PULPDENT FLUORIDE VARNISH
K093620 · Pulpdent Corporation · Mar 2010
VANISH VARNISH, 5% SODIUM FLUORIDE VARNISH, MODEL 12245, VANISH VARNISH, 5% FLUORIDE VARNISH, MODEL 12247
K090519 · 3M Company · Apr 2009
VOCO PROFLUORID L
K083036 · Voco GmbH · Jan 2009
VOCO PROFLUORID VARNISH
K080814 · Voco GmbH · Jul 2008
FLOR-OPAL VARNISH WHITE
K080249 · Ultradent Products, Inc. · Feb 2008