Dimensional Bioceramics Calcium Sulfate Device (DB-CSD)

Filler, Bone Void, Calcium Compound

Dimensional Bioceramics LLC

The following data is part of a premarket notification filed by Dimensional Bioceramics Llc with the FDA for Dimensional Bioceramics Calcium Sulfate Device (db-csd).

Pre-market Notification Details

Device IDK171161
510k NumberK171161
Device Name:Dimensional Bioceramics Calcium Sulfate Device (DB-CSD)
ClassificationFiller, Bone Void, Calcium Compound
Applicant Dimensional Bioceramics LLC 163 McKenzie Creek Road Scotts Valley,  CA  95066
ContactDavid Delaney
CorrespondentPatsy J. Trisler
Trisler Consulting 5600 Wisconsin Avenue #509 Chevy Chase,  MD  20815
Product CodeMQV  
CFR Regulation Number888.3045 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-04-20
Decision Date2017-09-25
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00850018568210 K171161 000
00850018568203 K171161 000
00850018568197 K171161 000

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