FLEXTIME

Material, Impression

HERAEUS KULZER, INC.

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

Pre-market Notification Details

• Device ID: K000629
• 510k Number: K000629
• Device Name: FLEXTIME
• 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: 2000-02-24
• Decision Date: 2000-04-05

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00850007728250	K000629	000