NORIAN PERIODONTAL/DENTAL CEMENT (PDC)

Bone Grafting Material, Synthetic

NORIAN CORP.

The following data is part of a premarket notification filed by Norian Corp. with the FDA for Norian Periodontal/dental Cement (pdc).

Pre-market Notification Details

Device IDK983104
510k NumberK983104
Device Name:NORIAN PERIODONTAL/DENTAL CEMENT (PDC)
ClassificationBone Grafting Material, Synthetic
Applicant NORIAN CORP. 10260 BUBB RD. Cupertino,  CA  95014 -4166
ContactKim Tompkins
CorrespondentKim Tompkins
NORIAN CORP. 10260 BUBB RD. Cupertino,  CA  95014 -4166
Product CodeLYC  
CFR Regulation Number872.3930 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-09-04
Decision Date1999-02-12
Summary:summary

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