Cleared Abbreviated

K100062 - INFILTRATION KIT

K100062 is an FDA 510(k) clearance for INFILTRATION KIT, manufactured by Dmg USA, Inc.. The device is a Class 2 Dental device with product code EBC cleared through the Abbreviated 510(k) pathway after a 74-day FDA review.

K100062 · Dmg USA, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2010
Decision
74d
Days
Class 2
Risk

K100062 is an FDA 510(k) clearance for the INFILTRATION KIT. Classified as Sealant, Pit And Fissure, And Conditioner (product code EBC), Class II - Special Controls.

Submitted by Dmg USA, Inc. (Attleboro, US). The FDA issued a Cleared decision on March 26, 2010 after a review of 74 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3765 - the FDA dental device regulatory framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Dmg USA, Inc. devices

FDA 510(k) Submission Details - K100062

510(k) Number K100062 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 11, 2010
Decision Date March 26, 2010
Days to Decision 74 days
Submission Type Abbreviated
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
53d faster than avg
Panel avg: 127d · This submission: 74d
Pathway characteristics
Standards-based clearance path.

EBC Device Classification - Class 2, Special Controls

Product Code EBC Sealant, Pit And Fissure, And Conditioner
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3765
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 - EBC Sealant, Pit And Fissure, And Conditioner

All 91
Devices cleared under the same product code (EBC) and FDA review panel - the closest regulatory comparables to K100062.
BEAUTISEALANT
K111782 · Shofu Dental Corporation · Sep 2011
ECO-S
K103121 · Vericom Co., Ltd. · Oct 2010
ULTRASEAL ID
K101245 · Ultradent Products, Inc. · Sep 2010
SPK SEALANT
K091632 · 3M Company · Sep 2009
INFILTRATION KIT
K081493 · Dmg USA, Inc. · Sep 2008
ASCENT PIT AND FISSURE SEALANT, MODEL 006-00019
K062886 · CAO Group, Inc. · Nov 2006