GRANDIO 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 Grandio Seal.

Pre-market Notification Details

Device IDK062344
510k NumberK062344
Device Name:GRANDIO SEAL
ClassificationSealant, Pit And Fissure, And Conditioner
Applicant VOCO GMBH ANTON-FLETTNER-STRASSE 1-3 Cuxhaven,  DE D-27472
ContactMichael Sues
CorrespondentMichael Sues
VOCO GMBH ANTON-FLETTNER-STRASSE 1-3 Cuxhaven,  DE D-27472
Product CodeEBC  
CFR Regulation Number872.3765 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-08-11
Decision Date2006-10-02

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
E22110611 K062344 000
E22110601 K062344 000

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