MONDIAL

Denture, Plastic, Teeth

HERAEUS KULZER, INC.

The following data is part of a premarket notification filed by Heraeus Kulzer, Inc. with the FDA for Mondial.

Pre-market Notification Details

• Device ID: K060994
• 510k Number: K060994
• Device Name: MONDIAL
• Classification: Denture, Plastic, Teeth
• Applicant: HERAEUS KULZER, INC. 4315 SOUTH LAFAYETTE BLVD. South Bend, IN 46614
• Contact: Cheryl V Zimmerman
• Correspondent: Cheryl V Zimmerman; HERAEUS KULZER, INC. 4315 SOUTH LAFAYETTE BLVD. South Bend, IN 46614
• Product Code: ELM
• CFR Regulation Number: 872.3590 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2006-04-11
• Decision Date: 2006-05-22