EVERBOND

Agent, Tooth Bonding, Resin

ESPE DENTAL AG

The following data is part of a premarket notification filed by Espe Dental Ag with the FDA for Everbond.

Pre-market Notification Details

• Device ID: K983414
• 510k Number: K983414
• Device Name: EVERBOND
• Classification: Agent, Tooth Bonding, Resin
• Applicant: ESPE DENTAL AG ESPE PLATZ Seefeld, Bavaria, DE D-82229
• Contact: A. Petermann
• Correspondent: A. Petermann; ESPE DENTAL AG ESPE PLATZ Seefeld, Bavaria, DE D-82229
• Product Code: KLE
• CFR Regulation Number: 872.3200 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1998-09-28
• Decision Date: 1998-12-16
• Summary: summary