FLEXITIME XTREME

Material, Impression

HERAEUS KULZER, INC.

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

Pre-market Notification Details

• Device ID: K042878
• 510k Number: K042878
• Device Name: FLEXITIME XTREME
• Classification: Material, Impression
• Applicant: HERAEUS KULZER, INC. 4315 SOUTH LAFAYETTE BLVD. South Bend, IN 46614 -2517
• Contact: Cheryl V Zimmerman
• Correspondent: Cheryl V Zimmerman; HERAEUS KULZER, INC. 4315 SOUTH LAFAYETTE BLVD. South Bend, IN 46614 -2517
• Product Code: ELW
• CFR Regulation Number: 872.3660 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2004-10-18
• Decision Date: 2004-12-17