EXPANSION SCREWS

Retainer, Screw Expansion, Orthodontic

FORESTADENT

The following data is part of a premarket notification filed by Forestadent with the FDA for Expansion Screws.

Pre-market Notification Details

• Device ID: K925088
• 510k Number: K925088
• Device Name: EXPANSION SCREWS
• Classification: Retainer, Screw Expansion, Orthodontic
• Applicant: FORESTADENT 7530 PFORZHEIM WESTLICHE 151 POSTFACH 660 Germany, DE
• Contact: Bernhard Forster
• Correspondent: Bernhard Forster; FORESTADENT 7530 PFORZHEIM WESTLICHE 151 POSTFACH 660 Germany, DE
• Product Code: DYJ
• CFR Regulation Number: 872.5410 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1992-10-07
• Decision Date: 1993-05-22