Cleared Traditional

K073101 - AURAVENEER CEMENT

K073101 is an FDA 510(k) clearance for AURAVENEER CEMENT, manufactured by Denali Corporation. The device is a Class 2 Dental device with product code EMA cleared through the Traditional 510(k) pathway after a 93-day FDA review.

K073101 · Denali Corporation · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2008
Decision
93d
Days
Class 2
Risk

K073101 is an FDA 510(k) clearance for the AURAVENEER CEMENT. Classified as Cement, Dental (product code EMA), Class II - Special Controls.

Submitted by Denali Corporation (Hanover, US). The FDA issued a Cleared decision on January 17, 2008 after a review of 93 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3275 - 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 - K073101

510(k) Number K073101 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 16, 2007
Decision Date January 17, 2008
Days to Decision 93 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
35d faster than avg
Panel avg: 128d · This submission: 93d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EMA Device Classification - Class 2, Special Controls

Product Code EMA Cement, Dental
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3275
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 - EMA Cement, Dental

All 460
Devices cleared under the same product code (EMA) and FDA review panel - the closest regulatory comparables to K073101.
SECURE
K073698 · Parkell, Inc. · Mar 2008
GC GAM-100
K073283 · GC America, Inc. · Feb 2008
SELF-ADHESIVE RESIN CEMENT
K073173 · Dentsply Interntional · Jan 2008
GILB-2, GLASS IONOMER PROTECTIVE COATING
K073395 · 3M Espe Dental Products · Jan 2008
SET PP
K073043 · Sdi , Ltd. · Dec 2007
DUO TEMP
K072604 · Coltene/Whaledent AG · Nov 2007