HARALD NORDIN CARBONITE CARBON FIBER COMPOSITE DENTAL POST

Post, Root Canal

HARALD NORDIN S.A

The following data is part of a premarket notification filed by Harald Nordin S.a with the FDA for Harald Nordin Carbonite Carbon Fiber Composite Dental Post.

Pre-market Notification Details

Device IDK003219
510k NumberK003219
Device Name:HARALD NORDIN CARBONITE CARBON FIBER COMPOSITE DENTAL POST
ClassificationPost, Root Canal
Applicant HARALD NORDIN S.A 100 MAIN STREET; SUITE 120 Concord,  MA  01742
ContactJames Delaney
CorrespondentJames Delaney
HARALD NORDIN S.A 100 MAIN STREET; SUITE 120 Concord,  MA  01742
Product CodeELR  
CFR Regulation Number872.3810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-10-16
Decision Date2000-10-25

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