MULTILINK

Cement, Dental

IVOCLAR VIVADENT, INC.

The following data is part of a premarket notification filed by Ivoclar Vivadent, Inc. with the FDA for Multilink.

Pre-market Notification Details

• Device ID: K032470
• 510k Number: K032470
• Device Name: MULTILINK
• Classification: Cement, Dental
• Applicant: IVOCLAR VIVADENT, INC. 175 PINEVIEW DR. Amherst, NY 14228
• Contact: Donna M Hartnett
• Correspondent: Donna M Hartnett; IVOCLAR VIVADENT, INC. 175 PINEVIEW DR. Amherst, NY 14228
• Product Code: EMA
• CFR Regulation Number: 872.3275 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: Yes
• Date Received: 2003-08-11
• Decision Date: 2003-11-05