PRELUDE

Agent, Tooth Bonding, Resin

DANVILLE MATERIALS, INC.

The following data is part of a premarket notification filed by Danville Materials, Inc. with the FDA for Prelude.

Pre-market Notification Details

• Device ID: K040952
• 510k Number: K040952
• Device Name: PRELUDE
• Classification: Agent, Tooth Bonding, Resin
• Applicant: DANVILLE MATERIALS, INC. 2021 OMEGA DR. San Ramon, CA 94583
• Contact: Craig Burns
• Correspondent: Craig Burns; DANVILLE MATERIALS, INC. 2021 OMEGA DR. San Ramon, CA 94583
• Product Code: KLE
• CFR Regulation Number: 872.3200 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: Yes
• Date Received: 2004-04-12
• Decision Date: 2004-06-29
• Summary: summary