IngeniOS ß-TCP Bioactiv Synthetic Bone Particles 1x0.5cc

GUDID 04260476431104

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 ID: 04260476431104
• NIH Device Record Key: 1e716628-f75d-4d98-9d36-dd43d2791743
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IngeniOS ß-TCP Bioactiv Synthetic Bone Particles
• Version Model Number: 1-2mm
• Catalog Number: 1x0.5cc
• 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	04260476431104 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K103709

FDA Product Code

• LPK: Bone Grafting Material, For Dental Bone Repair

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 ß-TCP Bioactiv Synthetic Bone Particles]

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