PADLOCK

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 Padlock.

Pre-market Notification Details

• Device ID: K111814
• 510k Number: K111814
• Device Name: PADLOCK
• Classification: Adhesive, Bracket And Tooth Conditioner, Resin
• Applicant: RELIANCE ORTHODONTIC PRODUCTS, INC. 1540 WEST THORNDALE AVE. Itasca, IL 60143
• Contact: Paula Wendland
• Correspondent: Paula Wendland; RELIANCE ORTHODONTIC PRODUCTS, INC. 1540 WEST THORNDALE AVE. Itasca, IL 60143
• Product Code: DYH
• CFR Regulation Number: 872.3750 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2011-06-27
• Decision Date: 2011-09-14
• Summary: summary