GLUMA ONE BOND

Agent, Tooth Bonding, Resin

HERAEUS KULZER, INC.

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

Pre-market Notification Details

• Device ID: K974390
• 510k Number: K974390
• Device Name: GLUMA ONE BOND
• Classification: Agent, Tooth Bonding, Resin
• 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: KLE
• CFR Regulation Number: 872.3200 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1997-11-21
• Decision Date: 1998-02-04
• Summary: summary