FLEX GOLD

Bracket, Metal, Orthodontic

FLEXMEDICS

The following data is part of a premarket notification filed by Flexmedics with the FDA for Flex Gold.

Pre-market Notification Details

• Device ID: K873649
• 510k Number: K873649
• Device Name: FLEX GOLD
• Classification: Bracket, Metal, Orthodontic
• Applicant: FLEXMEDICS 620 FORD CTR., 420 N. FIFTH STREET Minneapolis, MN 55401
• Contact: Sievert, Jr.
• Correspondent: Sievert, Jr.; FLEXMEDICS 620 FORD CTR., 420 N. FIFTH STREET Minneapolis, MN 55401
• Product Code: EJF
• CFR Regulation Number: 872.5410 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1987-09-09
• Decision Date: 1987-10-05