CONTROL SEAL

Sealant, Pit And Fissure, And Conditioner

VOCO GMBH

The following data is part of a premarket notification filed by Voco Gmbh with the FDA for Control Seal.

Pre-market Notification Details

• Device ID: K130485
• 510k Number: K130485
• Device Name: CONTROL SEAL
• Classification: Sealant, Pit And Fissure, And Conditioner
• 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: EBC
• CFR Regulation Number: 872.3765 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2013-02-25
• Decision Date: 2014-02-11

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
E22113031	K130485	000