IngeniOS ß-TCP Bioactiv Synthetic Bone Particles 1x2cc

GUDID 04260476431036

Device Name: IngeniOS ß-TCP Bioactiv Synthetic Bone Particles Indications for Use: Oral and maxillofacial surgery and dentistry • Augmentation or reconstructive treatment of the alveolar ridge • Filling of infrabony periodontal defects • Filling of defects after root resection, apicoectomy, and cystectomy • Filing of extraction sockets to enhance preservation of the alveolar ridge • Elevation of the maxillary sinus floor

curasan AG

Dental bone matrix implant, synthetic
Primary Device ID04260476431036
NIH Device Record Keycad4bcd8-7e6a-4b7b-9af5-4143e6393a70
Commercial Distribution StatusIn Commercial Distribution
Brand NameIngeniOS ß-TCP Bioactiv Synthetic Bone Particles
Version Model Number0.25-1mm
Catalog Number1x2cc
Company DUNS324331826
Company Namecurasan AG
Device Count1
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 Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+496027409000
Emailinfo@curasan.de

Device Identifiers

Device Issuing AgencyDevice ID
GS104260476431036 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LPKBone Grafting Material, For Dental Bone Repair

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-11-07
Device Publish Date2019-10-30

On-Brand Devices [IngeniOS ß-TCP Bioactiv Synthetic Bone Particles]

42604764311288Device Name: IngeniOS ß-TCP Bioactiv Synthetic Bone Particles Indications for Use: Oral and max
42604764311110Device Name: IngeniOS ß-TCP Bioactiv Synthetic Bone Particles Indications for Use: Oral and max
42604764311042Device Name: IngeniOS ß-TCP Bioactiv Synthetic Bone Particles Indications for Use: Oral and max
42604764310366Device Name: IngeniOS ß-TCP Bioactiv Synthetic Bone Particles Indications for Use: Oral and max
42604764310298Device Name: IngeniOS ß-TCP Bioactiv Synthetic Bone Particles Indications for Use: Oral and max
42604764310120Device Name: IngeniOS ß-TCP Bioactiv Synthetic Bone Particles Indications for Use: Oral and max
42604764310052Device Name: IngeniOS ß-TCP Bioactiv Synthetic Bone Particles Indications for Use: Oral and max
04260476431128Device Name: IngeniOS ß-TCP Bioactiv Synthetic Bone Particles Indications for Use: Oral and max
04260476431111Device Name: IngeniOS ß-TCP Bioactiv Synthetic Bone Particles Indications for Use: Oral and max
04260476431104Device Name: IngeniOS ß-TCP Bioactiv Synthetic Bone Particles Indications for Use: Oral and max
04260476431036Device Name: IngeniOS ß-TCP Bioactiv Synthetic Bone Particles Indications for Use: Oral and max
04260476431029Device Name: IngeniOS ß-TCP Bioactiv Synthetic Bone Particles Indications for Use: Oral and max
04260476431012Device Name: IngeniOS ß-TCP Bioactiv Synthetic Bone Particles Indications for Use: Oral and max
04260476431005Device Name: IngeniOS ß-TCP Bioactiv Synthetic Bone Particles Indications for Use: Oral and max

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