Cleared Traditional

K122708 - REMESENSE FOR SENSITIVE TEETH (FDA 510(k) Clearance)

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

K122708 · Sylphar N.V. · Dental device
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Jan 2013
Decision
132d
Days
Class 2
Risk

K122708 is an FDA 510(k) clearance for the REMESENSE FOR SENSITIVE TEETH. Classified as Varnish, Cavity (product code LBH), Class II - Special Controls.

Submitted by Sylphar N.V. (Rome, IT). The FDA issued a Cleared decision on January 14, 2013 after a review of 132 days - within the typical 510(k) review window.

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 Sylphar N.V. devices

Submission Details

510(k) Number K122708 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 04, 2012
Decision Date January 14, 2013
Days to Decision 132 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
5d slower than avg
Panel avg: 127d · This submission: 132d
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 K122708.
VOCO Profluorid Varnish + BioMin
K252073 · Voco GmbH · May 2026
UltraEZ
K261404 · Ultradent Products, Inc. · Apr 2026
APAPRO Desensitizer Homecare (Remineralizing Anti-sensitivity Toothpaste)
K260830 · Sangi Co, Ltd. · Mar 2026
FluoroDose Varnish
K250714 · Centrix, Inc. · Nov 2025
Rennou™ Varnish (3% / Spearmint)
K243777 · Theodent, LLC · May 2025
ReminGel
K241489 · Inter-Med, Inc. · Jan 2025