OPTIFLEX

Bracket, Metal, Orthodontic

ORMCO CORP.

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

Pre-market Notification Details

• Device ID: K894781
• 510k Number: K894781
• Device Name: OPTIFLEX
• Classification: Bracket, Metal, Orthodontic
• Applicant: ORMCO CORP. 1332 SOUTH LONE HILL AVE. Glendora, CA 91740
• Contact: Frances Zee
• Correspondent: Frances Zee; ORMCO CORP. 1332 SOUTH LONE HILL AVE. Glendora, CA 91740
• Product Code: EJF
• CFR Regulation Number: 872.5410 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1989-07-28
• Decision Date: 1989-09-15