MERIDIAN

Material, Tooth Shade, Resin

AB ARDENT

The following data is part of a premarket notification filed by Ab Ardent with the FDA for Meridian.

Pre-market Notification Details

• Device ID: K131753
• 510k Number: K131753
• Device Name: MERIDIAN
• Classification: Material, Tooth Shade, Resin
• Applicant: AB ARDENT 175 PINEVIEW DRIVE Amherst, NY 14228
• Contact: Donna Marie Hartnett
• Correspondent: Donna Marie Hartnett; AB ARDENT 175 PINEVIEW DRIVE Amherst, NY 14228
• Product Code: EBF
• CFR Regulation Number: 872.3690 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Abbreviated
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2013-06-14
• Decision Date: 2013-11-14
• Summary: summary