EVOLVE

Adhesive, Bracket And Tooth Conditioner, Resin

RELIANCE ORTHODONTIC PRODUCTS, INC.

The following data is part of a premarket notification filed by Reliance Orthodontic Products, Inc. with the FDA for Evolve.

Pre-market Notification Details

• Device ID: K033551
• 510k Number: K033551
• Device Name: EVOLVE
• Classification: Adhesive, Bracket And Tooth Conditioner, Resin
• Applicant: RELIANCE ORTHODONTIC PRODUCTS, INC. 1100 W. IRVING PARK RD. Schaumburg, IL 60193
• Contact: Benjamin Lichtenwalner
• Correspondent: Benjamin Lichtenwalner; RELIANCE ORTHODONTIC PRODUCTS, INC. 1100 W. IRVING PARK RD. Schaumburg, IL 60193
• Product Code: DYH
• CFR Regulation Number: 872.3750 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2003-11-10
• Decision Date: 2003-12-16
• Summary: summary