OSSIX BONE

Bone Grafting Material, Animal Source

Datum Dental Ltd

The following data is part of a premarket notification filed by Datum Dental Ltd with the FDA for Ossix Bone.

Pre-market Notification Details

Device IDK163714
510k NumberK163714
Device Name:OSSIX BONE
ClassificationBone Grafting Material, Animal Source
Applicant Datum Dental Ltd 1 Bat Sheva St., PO Box 6170 Lod,  IL 7116003
ContactArie Goldlust
CorrespondentJanice M Hogan
HOGAN LOVELLS US LLP 1835 MARKET ST, 29TH FL Philadelphia,  PA  19103
Product CodeNPM  
CFR Regulation Number872.3930 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-12-30
Decision Date2017-07-18
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07290015477253 K163714 000
07290015477222 K163714 000
07290015477215 K163714 000

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