Osbone Dental 5 x 0.5 cc

GUDID ECURH05M0250

Device Name: OSBONE® DENTAL lndications for Use: OSBONE® DENTAL is intended for the filling and reconstruction of multi-walled bone defects, e.g.: - Defects after removal of bone cysts - Augmentation of the atrophied alveolar ridge - Sinus lift and sinus floor elevation (subantral augmentation) - Filling of alveolar defects following tooth extraction for alveolar ridge preservation - Filling of extraction defects to create an implant bed - Filling of two- or multi-walled infrabony pockets, and bi- and trifurcation defects - Support function for a membrane in controlled tissue regeneration (CTR) - Defects after surgical removal of retained teeth or corrective osteotomies - Other multi-walled bone defects of the alveolar processes

curasan AG

Synthetic bone graft
Primary Device IDECURH05M0250
NIH Device Record Keyac3ec345-d18a-4dfd-b2b3-59767806ad61
Commercial Distribution StatusIn Commercial Distribution
Brand NameOsbone Dental
Version Model Number250-1000µm
Catalog Number5 x 0.5 cc
Company DUNS324331826
Company Namecurasan AG
Device Count5
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone+496027409000
Emailinfo@curasan.de

Device Dimensions

Total Volume0.5 Centiliter

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCECURH05M0250 [Primary]
HIBCCECURH05M02505 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LYCBone Grafting Material, Synthetic

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-02-11

On-Brand Devices [Osbone Dental]

ECURH20V0250Device Name: OSBONE® DENTAL lndications for Use: OSBONE® DENTAL is intended for the filling a
ECURH20M1000Device Name: OSBONE® DENTAL lndications for Use: OSBONE® DENTAL is intended for the filling a
ECURH10V1000Device Name: OSBONE® DENTAL lndications for Use: OSBONE® DENTAL is intended for the filling a
ECURH10V0250Device Name: OSBONE® DENTAL lndications for Use: OSBONE® DENTAL is intended for the filling a
ECURH10M1000Device Name: OSBONE® DENTAL lndications for Use: OSBONE® DENTAL is intended for the filling a
ECURH10M0250Device Name: OSBONE® DENTAL lndications for Use: OSBONE® DENTAL is intended for the filling a
ECURH05V1000Device Name: OSBONE® DENTAL lndications for Use: OSBONE® DENTAL is intended for the filling a
ECURH05V0250Device Name: OSBONE® DENTAL lndications for Use: OSBONE® DENTAL is intended for the filling
ECURH05M1000Device Name: OSBONE® DENTAL lndications for Use: OSBONE® DENTAL is intended for the filling a
ECURH05M0250Device Name: OSBONE® DENTAL lndications for Use: OSBONE® DENTAL is intended for the filling

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