GRENGLOO

Adhesive, Bracket And Tooth Conditioner, Resin

ORMCO CORP.

The following data is part of a premarket notification filed by Ormco Corp. with the FDA for Grengloo.

Pre-market Notification Details

• Device ID: K061481
• 510k Number: K061481
• Device Name: GRENGLOO
• Classification: Adhesive, Bracket And Tooth Conditioner, Resin
• Applicant: ORMCO CORP. 100 BAYVIEW CIRCLE SUITE 6000 Newport Beach, CA 92660
• Contact: Colleen Boswell
• Correspondent: Colleen Boswell; ORMCO CORP. 100 BAYVIEW CIRCLE SUITE 6000 Newport Beach, CA 92660
• Product Code: DYH
• CFR Regulation Number: 872.3750 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2006-05-30
• Decision Date: 2006-07-06
• Summary: summary