HELIOLUX

Activator, Ultraviolet, For Polymerization

IVOCLAR NORTH AMERICA, INC.

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

Pre-market Notification Details

• Device ID: K913980
• 510k Number: K913980
• Device Name: HELIOLUX
• Classification: Activator, Ultraviolet, For Polymerization
• 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: EBZ
• CFR Regulation Number: 872.6070 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1991-09-06
• Decision Date: 1991-12-16