MICROPRIME

Agent, Tooth Bonding, Resin

DANVILLE ENGINEERING, INC.

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

Pre-market Notification Details

• Device ID: K953504
• 510k Number: K953504
• Device Name: MICROPRIME
• Classification: Agent, Tooth Bonding, Resin
• Applicant: DANVILLE ENGINEERING, INC. 1901 SAN RAMON VALLEY BLVD. San Ramon, CA 94583
• Contact: Craig R Bruns
• Correspondent: Craig R Bruns; DANVILLE ENGINEERING, INC. 1901 SAN RAMON VALLEY BLVD. San Ramon, CA 94583
• Product Code: KLE
• CFR Regulation Number: 872.3200 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1995-07-26
• Decision Date: 1995-10-03

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00816577022112	K953504	000
00359883006501	K953504	000