VIVALUX

Material, Tooth Shade, Resin

IVOCLAR NORTH AMERICA, INC.

The following data is part of a premarket notification filed by Ivoclar North America, Inc. with the FDA for Vivalux.

Pre-market Notification Details

• Device ID: K926556
• 510k Number: K926556
• Device Name: VIVALUX
• Classification: Material, Tooth Shade, Resin
• Applicant: IVOCLAR NORTH AMERICA, INC. 175 PINEVIEW DR. Amherst, NY 14228
• Contact: Lloyd V Ziemendorf
• Correspondent: Lloyd V Ziemendorf; IVOCLAR NORTH AMERICA, INC. 175 PINEVIEW DR. Amherst, NY 14228
• Product Code: EBF
• CFR Regulation Number: 872.3690 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1992-12-31
• Decision Date: 1993-04-23