AURA

Material, Tooth Shade, Resin

SDI LIMITED

The following data is part of a premarket notification filed by Sdi Limited with the FDA for Aura.

Pre-market Notification Details

• Device ID: K102984
• 510k Number: K102984
• Device Name: AURA
• Classification: Material, Tooth Shade, Resin
• Applicant: SDI LIMITED 3-13 BRUNSDON STREET Bayswater, Victoria, AU 3153
• Contact: Ruth Ezekiel
• Correspondent: Ruth Ezekiel; SDI LIMITED 3-13 BRUNSDON STREET Bayswater, Victoria, AU 3153
• Product Code: EBF
• CFR Regulation Number: 872.3690 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2010-10-07
• Decision Date: 2010-12-08