IngeniOS HA 1x1cc

GUDID 04260476431319

Device Name: IngeniOS HA Indications for Use: Oral-maxillofacial surgery, dentistry, implantology, periodontology • Defects after removal of bone cysts • Augmentation of the atrophied alveolar ridge • 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 guided tissue regeneration (GTR) • Defects after surgical removal of retained teeth or corrective osteotomies • Other multi-walled bone defects of the alveolar ridge

curasan AG

Synthetic bone graft
Primary Device ID04260476431319
NIH Device Record Key2818e50b-c5da-4513-8ac0-91176dc50858
Commercial Distribution StatusIn Commercial Distribution
Brand NameIngeniOS HA
Version Model Number1-2mm
Catalog Number1x1cc
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
GS104260476431319 [Primary]

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

On-Brand Devices [IngeniOS HA]

42604764313268Device Name: IngeniOS HA Indications for Use: Oral-maxillofacial surgery, dentistry, implantolog
42604764313190Device Name: IngeniOS HA Indications for Use: Oral-maxillofacial surgery, dentistry, implantolog
42604764313022Device Name: IngeniOS HA Indications for Use: Oral-maxillofacial surgery, dentistry, implantolog
42604764312346Device Name: IngeniOS HA Indications for Use: Oral-maxillofacial surgery, dentistry, implantolog
42604764312278Device Name: IngeniOS HA Indications for Use: Oral-maxillofacial surgery, dentistry, implantolog
42604764312100Device Name: IngeniOS HA Indications for Use: Oral-maxillofacial surgery, dentistry, implantolog
42604764312032Device Name: IngeniOS HA Indications for Use: Oral-maxillofacial surgery, dentistry, implantolog
04260476431326Device Name: IngeniOS HA Indications for Use: Oral-maxillofacial surgery, dentistry, implantolog
04260476431319Device Name: IngeniOS HA Indications for Use: Oral-maxillofacial surgery, dentistry, implantolog
04260476431302Device Name: IngeniOS HA Indications for Use: Oral-maxillofacial surgery, dentistry, implantolog
04260476431234Device Name: IngeniOS HA Indications for Use: Oral-maxillofacial surgery, dentistry, implantolog
04260476431227Device Name: IngeniOS HA Indications for Use: Oral-maxillofacial surgery, dentistry, implantolog
04260476431210Device Name: IngeniOS HA Indications for Use: Oral-maxillofacial surgery, dentistry, implantolog
04260476431203Device Name: IngeniOS HA Indications for Use: Oral-maxillofacial surgery, dentistry, implantolog

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