Cleared Abbreviated

K080479 - DENTAL CERAMIC

K080479 is an FDA 510(k) clearance for DENTAL CERAMIC, manufactured by Dmg USA, Inc.. The device is a Class 2 Dental device with product code EIH cleared through the Abbreviated 510(k) pathway after a 89-day FDA review.

K080479 · Dmg USA, Inc. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2008
Decision
89d
Days
Class 2
Risk

K080479 is an FDA 510(k) clearance for the DENTAL CERAMIC. Classified as Powder, Porcelain (product code EIH), Class II - Special Controls.

Submitted by Dmg USA, Inc. (Ayer, US). The FDA issued a Cleared decision on May 21, 2008 after a review of 89 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6660 - 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.

FDA 510(k) Submission Details - K080479

510(k) Number K080479 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 22, 2008
Decision Date May 21, 2008
Days to Decision 89 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
39d faster than avg
Panel avg: 128d · This submission: 89d
Pathway characteristics
Standards-based clearance path.

EIH Device Classification - Class 2, Special Controls

Product Code EIH Powder, Porcelain
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.6660
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 - EIH Powder, Porcelain

All 471
Devices cleared under the same product code (EIH) and FDA review panel - the closest regulatory comparables to K080479.
STARCERAM
K081263 · H.C. Starck Ceramics GmbH & Co.Kg · Jul 2008
VINTAGE ART
K080834 · Shofu Dental Corp. · Jun 2008
ZIRKONDENT
K080146 · Ergometa · Jun 2008
ZIRDENT CAD/CAM BLOCKS
K081253 · C5 Medical Werks, Inc. · May 2008
NACERA Z AND NACERA Z MEDIUM
K080195 · Doceram Medical Ceramics GmbH · Apr 2008
HEANY INDUSTRIES INC DENTAL XIRCONIA
K073314 · Heany Industries, Inc. · Feb 2008