MIDIGOLD 50

Alloy, Gold-based Noble Metal

IVOCLAR NORTH AMERICA, INC.

The following data is part of a premarket notification filed by Ivoclar North America, Inc. with the FDA for Midigold 50.

Pre-market Notification Details

• Device ID: K905322
• 510k Number: K905322
• Device Name: MIDIGOLD 50
• Classification: Alloy, Gold-based Noble Metal
• Applicant: IVOCLAR NORTH AMERICA, INC. 175 PINEVIEW DR. Amherst, NY 14228
• Contact: Gary L Severance
• Correspondent: Gary L Severance; IVOCLAR NORTH AMERICA, INC. 175 PINEVIEW DR. Amherst, NY 14228
• Product Code: EJT
• CFR Regulation Number: 872.3060 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1990-11-28
• Decision Date: 1991-01-16