IONOSIT BASE LINER

Coating, Filling Material, Resin

FOREMOST DENTAL MFG., CO.

The following data is part of a premarket notification filed by Foremost Dental Mfg., Co. with the FDA for Ionosit Base Liner.

Pre-market Notification Details

Device IDK935689
510k NumberK935689
Device Name:IONOSIT BASE LINER
ClassificationCoating, Filling Material, Resin
Applicant FOREMOST DENTAL MFG., CO. 242 S. DEAN ST. Englewood,  NJ  07631
ContactD.t. Wolf
CorrespondentD.t. Wolf
FOREMOST DENTAL MFG., CO. 242 S. DEAN ST. Englewood,  NJ  07631
Product CodeEBD  
CFR Regulation Number872.3310 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-11-29
Decision Date1994-01-21

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
EDMG22911 K935689 000
EDMG2230021 K935689 000
EDMG2109111 K935689 000

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