X-TRA BASE

Material, Tooth Shade, Resin

VOCO GMBH

The following data is part of a premarket notification filed by Voco Gmbh with the FDA for X-tra Base.

Pre-market Notification Details

• Device ID: K123773
• 510k Number: K123773
• Device Name: X-TRA BASE
• Classification: Material, Tooth Shade, Resin
• Applicant: VOCO GMBH ANTON-FLETTNER-STRASSE 1-3 Cuxhaven, DE D-27472
• Contact: T. Gerkensmeier
• Correspondent: T. Gerkensmeier; VOCO GMBH ANTON-FLETTNER-STRASSE 1-3 Cuxhaven, DE D-27472
• Product Code: EBF
• CFR Regulation Number: 872.3690 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2012-12-07
• Decision Date: 2012-12-21