REPROBONE DENTAL GRAFTING MATERIAL

Bone Grafting Material, Synthetic

CERAMISYS LTD

The following data is part of a premarket notification filed by Ceramisys Ltd with the FDA for Reprobone Dental Grafting Material.

Pre-market Notification Details

Device IDK103820
510k NumberK103820
Device Name:REPROBONE DENTAL GRAFTING MATERIAL
ClassificationBone Grafting Material, Synthetic
Applicant CERAMISYS LTD 344 ANNABELLE POINT ROAD Centerville,  MA  02632 -2402
ContactHillard W Welch
CorrespondentHillard W Welch
CERAMISYS LTD 344 ANNABELLE POINT ROAD Centerville,  MA  02632 -2402
Product CodeLYC  
CFR Regulation Number872.3930 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-12-30
Decision Date2011-11-03
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
05060171623458 K103820 000
05060171623298 K103820 000
05060171623304 K103820 000
05060171623311 K103820 000
05060171623328 K103820 000
05060171623335 K103820 000
05060171623342 K103820 000
05060171623359 K103820 000
05060171623366 K103820 000
05060171623373 K103820 000
05060171623380 K103820 000
05060171623397 K103820 000
05060171623403 K103820 000
05060171623410 K103820 000
05060171623427 K103820 000
05060171623434 K103820 000
05060171623441 K103820 000
05060171623281 K103820 000

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