Cleared Abbreviated

K080480 - NANOCOMPOSITE RESTORATIVE KIT

K080480 is an FDA 510(k) clearance for NANOCOMPOSITE RESTORATIVE KIT, manufactured by Dmg USA, Inc.. The device is a Class 2 Dental device with product code EBF cleared through the Abbreviated 510(k) pathway after a 98-day FDA review.

K080480 · Dmg USA, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2008
Decision
98d
Days
Class 2
Risk

K080480 is an FDA 510(k) clearance for the NANOCOMPOSITE RESTORATIVE KIT. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Dmg USA, Inc. (Ayer, US). The FDA issued a Cleared decision on May 30, 2008 after a review of 98 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3690 - 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 - K080480

510(k) Number K080480 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 22, 2008
Decision Date May 30, 2008
Days to Decision 98 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
29d faster than avg
Panel avg: 127d · This submission: 98d
Pathway characteristics
Standards-based clearance path.

EBF Device Classification - Class 2, Special Controls

Product Code EBF Material, Tooth Shade, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3690
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 - EBF Material, Tooth Shade, Resin

All 684
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K080480.
GRADIA CORE
K082171 · GC America, Inc. · Oct 2008
ESTELITE SIGMA QUICK
K080940 · Tokuyama Dental Corporation · Jun 2008
GRADIA FORTE
K080478 · GC America, Inc. · Jun 2008
NEXCOMP AND META ETCHANT
K080305 · Meta Biomed Co., Ltd. · Apr 2008
BEAUTIFIL OPAQUER
K080068 · Shofu Dental Corp. · Feb 2008
3M ESPE ADULT CROWN
K072733 · 3M Company · Feb 2008