HEMA-GLU

Agent, Tooth Bonding, Resin

HEALTH-DENT INTL., INC.

The following data is part of a premarket notification filed by Health-dent Intl., Inc. with the FDA for Hema-glu.

Pre-market Notification Details

• Device ID: K951220
• 510k Number: K951220
• Device Name: HEMA-GLU
• Classification: Agent, Tooth Bonding, Resin
• Applicant: HEALTH-DENT INTL., INC. 118 WEST LAKE ST. Northlake, IL 60164
• Contact: Al Bevilacqua
• Correspondent: Al Bevilacqua; HEALTH-DENT INTL., INC. 118 WEST LAKE ST. Northlake, IL 60164
• Product Code: KLE
• CFR Regulation Number: 872.3200 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1995-03-20
• Decision Date: 1995-05-12