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 ID: 04260476431319
• NIH Device Record Key: 2818e50b-c5da-4513-8ac0-91176dc50858
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IngeniOS HA
• Version Model Number: 1-2mm
• Catalog Number: 1x1cc
• Company DUNS: 324331826
• Company Name: curasan AG
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +496027409000
• Email: info@curasan.de

Device Identifiers

Device Issuing Agency	Device ID
GS1	04260476431319 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K102872

FDA Product Code

• LYC: Bone Grafting Material, Synthetic

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-11-07
• Device Publish Date: 2019-10-30

On-Brand Devices [IngeniOS HA]

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