Cleared Traditional

K131248 - ETCH GEL

K131248 is an FDA 510(k) clearance for ETCH GEL, manufactured by Dmg America, LLC. The device is a Class 2 Dental device with product code KLE cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K131248 · Dmg America, LLC · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2013
Decision
71d
Days
Class 2
Risk

K131248 is an FDA 510(k) clearance for the ETCH GEL. Classified as Agent, Tooth Bonding, Resin (product code KLE), Class II - Special Controls.

Submitted by Dmg America, LLC (Ayer, US). The FDA issued a Cleared decision on July 11, 2013 after a review of 71 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3200 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Dmg America, LLC devices

FDA 510(k) Submission Details - K131248

510(k) Number K131248 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 01, 2013
Decision Date July 11, 2013
Days to Decision 71 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
56d faster than avg
Panel avg: 127d · This submission: 71d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KLE Device Classification - Class 2, Special Controls

Product Code KLE Agent, Tooth Bonding, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3200
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 - KLE Agent, Tooth Bonding, Resin

All 338
Devices cleared under the same product code (KLE) and FDA review panel - the closest regulatory comparables to K131248.
CLEARFIL DC ACTIVATOR
K131430 · Kuraray Noritake Dental, Inc. · Aug 2013
PREMIER CERAMIC PRIMER
K131212 · Premier Dental Products Co. · Aug 2013
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K131432 · Kuraray Noritake Dental, Inc. · Aug 2013
FUTURABOND UNIVERSAL
K130486 · Voco GmbH · Jun 2013
CERARESIN BOND
K123119 · Shofu Dental Corporation · Nov 2012
ES BOND
K120767 · Spident Co., Ltd. · May 2012