MAGNEFORCE

Spring, Orthodontic

ORMCO CORP.

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

Pre-market Notification Details

• Device ID: K943068
• 510k Number: K943068
• Device Name: MAGNEFORCE
• Classification: Spring, Orthodontic
• Applicant: ORMCO CORP. 1332 SOUTH LONE HILL AVE. Glendora, CA 91740
• Contact: Jeffrey A Anderson
• Correspondent: Jeffrey A Anderson; ORMCO CORP. 1332 SOUTH LONE HILL AVE. Glendora, CA 91740
• Product Code: ECO
• CFR Regulation Number: 872.5410 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1994-06-28
• Decision Date: 1994-08-17