G-FLOSS & G-FLOSS II

Floss, Dental

IMPLANT INNOVATIONS INTERNATIONAL, INC.

The following data is part of a premarket notification filed by Implant Innovations International, Inc. with the FDA for G-floss & G-floss Ii.

Pre-market Notification Details

Device IDK911701
510k NumberK911701
Device Name:G-FLOSS & G-FLOSS II
ClassificationFloss, Dental
Applicant IMPLANT INNOVATIONS INTERNATIONAL, INC. 1897 PALM BEACH LAKES BLVD. SUITE 114 West Palm Beach,  FL  33409
ContactWilliam G Conety
CorrespondentWilliam G Conety
IMPLANT INNOVATIONS INTERNATIONAL, INC. 1897 PALM BEACH LAKES BLVD. SUITE 114 West Palm Beach,  FL  33409
Product CodeJES  
CFR Regulation Number872.6390 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-04-16
Decision Date1991-05-15

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