Cleared Traditional

NEUN

K073554 · Heraeus Kulzer,GmbH · Dental
Feb 2008
Decision
48d
Days
Class 2
Risk

About This 510(k) Submission

K073554 is an FDA 510(k) clearance for the NEUN, a Material, Tooth Shade, Resin (Class II — Special Controls, product code EBF), submitted by Heraeus Kulzer,GmbH (South Bend, US). The FDA issued a Cleared decision on February 4, 2008, 48 days after receiving the submission on December 18, 2007. This device falls under the Dental review panel. Regulated under 21 CFR 872.3690.

Submission Details

510(k) Number K073554 FDA.gov
FDA Decision Cleared SESE
Date Received December 18, 2007
Decision Date February 04, 2008
Days to Decision 48 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

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