Cleared Traditional

K132109 - ENAMELAST

K132109 is an FDA 510(k) clearance for ENAMELAST, manufactured by Ultradent Products Inc. / Oratech, LLC. The device is a Class 2 Dental device with product code LBH cleared through the Traditional 510(k) pathway after a 116-day FDA review.

K132109 · Ultradent Products Inc. / Oratech, LLC · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2013
Decision
116d
Days
Class 2
Risk

K132109 is an FDA 510(k) clearance for the ENAMELAST. Classified as Varnish, Cavity (product code LBH), Class II - Special Controls.

Submitted by Ultradent Products Inc. / Oratech, LLC (Salt Lake City, US). The FDA issued a Cleared decision on November 1, 2013 after a review of 116 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.

FDA 510(k) Submission Details - K132109

510(k) Number K132109 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 08, 2013
Decision Date November 01, 2013
Days to Decision 116 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
12d faster than avg
Panel avg: 128d · This submission: 116d
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 128
Devices cleared under the same product code (LBH) and FDA review panel - the closest regulatory comparables to K132109.
STARBRIGHT 5% SODIUM FLUORIDE VARNISH
K140349 · Nanova Biomaterials, Inc. · Sep 2014
COLGATE DESENSITIZING MOUTHRINSE, COLGATE SENSITIVE PRO-RELIEF MOUTHWASH
K140481 · Colgate-Palmolive Company · Jun 2014
SYLPHAR REMESENSE SENSITIVITY RELIEF STRIPS
K132426 · Sylphar N.V. · Feb 2014
ALPHA-PRO WHITE VARNISH
K124025 · Dental Technologies, Inc. · Sep 2013
SMARTCOAT 2.5% NAF VARNISH
K131376 · Elevate Oral Care · Aug 2013
SEAL BLOCK PRO (NOT FINALIZED), SEAL BLOCK OTC (NOT FINALIZED)
K123653 · Bisco, Inc. · Jun 2013
K132109 · ENAMELAST
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