510(k) K103709

Device
CERACELL DENTAL
Applicant
CURASAN AG
510(k) number
K103709
Product code
LPK  
Decision
Substantially Equivalent (SESE)
Decision date
2011-03-10
Date received
2010-12-20
Regulation
872.3930
Classification name
Bone Grafting Material, For Dental Bone Repair
Medical specialty
Dental
Review panel
Dental
Device class
2
Clearance type
Abbreviated
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
ROGER GRAY
Address
Piazza Albania 10 Rome IT 00153 00153

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Legacy Summary#

summary

FDA Review#

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