Charisma

Material, Tooth Shade, Resin

Heraeus Kulzer, LLC (Mitsui Chemicals Group)

The following data is part of a premarket notification filed by Heraeus Kulzer, Llc (mitsui Chemicals Group) with the FDA for Charisma.

Pre-market Notification Details

• Device ID: K160049
• 510k Number: K160049
• Device Name: Charisma
• Classification: Material, Tooth Shade, Resin
• Applicant: Heraeus Kulzer, LLC (Mitsui Chemicals Group) 4315 S. Lafayette Blvd South Bend, IN 46614
• Contact: Jamie Cleveland
• Correspondent: Jamie Cleveland; Heraeus Kulzer, LLC (Mitsui Chemicals Group) 4315 S. Lafayette Blvd South Bend, IN 46614
• Product Code: EBF
• CFR Regulation Number: 872.3690 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2016-01-11
• Decision Date: 2016-11-15