Cleared Traditional

K122708 - REMESENSE FOR SENSITIVE TEETH

K122708 is an FDA 510(k) clearance for REMESENSE FOR SENSITIVE TEETH, manufactured by Sylphar N.V.. The device is a Class 2 Dental device with product code LBH cleared through the Traditional 510(k) pathway after a 132-day FDA review.

K122708 · Sylphar N.V. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K122708

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.

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 83
Devices cleared under the same product code (LBH) and FDA review panel - the closest regulatory comparables to K122708.
FLUOR PROTECTOR S
K131487 · Ivoclar Vivadent, AG · Oct 2014
SEAL BLOCK PRO (NOT FINALIZED), SEAL BLOCK OTC (NOT FINALIZED)
K123653 · Bisco, Inc. · Jun 2013
PRG BARRIER COAT
K122908 · Shofu Dental Corporation · Apr 2013
CAVITY VARNISH
K122331 · Dentsply International, Inc. · Oct 2012
SENZZZZZ AWAY
K120176 · Centrix, Inc. · Jul 2012
ACTIV VARNISH
K112946 · Pulpdent Corporation · Dec 2011