PREMIUM

Denture, Plastic, Teeth

HERAEUS KULZER, INC.

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

Pre-market Notification Details

• Device ID: K011130
• 510k Number: K011130
• Device Name: PREMIUM
• Classification: Denture, Plastic, Teeth
• Applicant: HERAEUS KULZER, INC. 99 BUSINESS PARK DR. Armonk, NY 10504
• Contact: Raphael Judkins
• Correspondent: Raphael Judkins; HERAEUS KULZER, INC. 99 BUSINESS PARK DR. Armonk, NY 10504
• Product Code: ELM
• CFR Regulation Number: 872.3590 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2001-04-13
• Decision Date: 2001-07-05