LIGHT BOND SEALANT WITH FLUORIDE

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 Light Bond Sealant With Fluoride.

Pre-market Notification Details

• Device ID: K894565
• 510k Number: K894565
• Device Name: LIGHT BOND SEALANT WITH FLUORIDE
• Classification: Adhesive, Bracket And Tooth Conditioner, Resin
• Applicant: RELIANCE ORTHODONTIC PRODUCTS, INC. P.O. BOX 678 Itasca, IL 60143
• Contact: Paul Gange
• Correspondent: Paul Gange; RELIANCE ORTHODONTIC PRODUCTS, INC. P.O. BOX 678 Itasca, IL 60143
• Product Code: DYH
• CFR Regulation Number: 872.3750 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1989-07-21
• Decision Date: 1989-10-13

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
D798S7B0	K894565	000
D798S7AF0	K894565	000
D798S20B0	K894565	000
D798S20AF0	K894565	000