Cleared Traditional

AURA

K102984 · Sdi Limited · Dental
Dec 2010
Decision
62d
Days
Class 2
Risk

About This 510(k) Submission

K102984 is an FDA 510(k) clearance for the AURA, a Material, Tooth Shade, Resin (Class II — Special Controls, product code EBF), submitted by Sdi Limited (Bayswater, AU). The FDA issued a Cleared decision on December 8, 2010, 62 days after receiving the submission on October 7, 2010. This device falls under the Dental review panel. Regulated under 21 CFR 872.3690.

Submission Details

510(k) Number K102984 FDA.gov
FDA Decision Cleared SESE
Date Received October 07, 2010
Decision Date December 08, 2010
Days to Decision 62 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

Device Classification

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