Osbone Dental 1 x 2.0 cc

GUDID ECURH20V0250

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 ID: ECURH20V0250
• NIH Device Record Key: 1a772f58-3955-452c-a923-36ba70d4ca13
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Osbone Dental
• Version Model Number: 250-1000µm
• Catalog Number: 1 x 2.0 cc
• 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: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	ECURH20V0250 [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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-02-11

On-Brand Devices [Osbone Dental]

• ECURH20V0250: Device Name: OSBONE® DENTAL lndications for Use: OSBONE® DENTAL is intended for the filling a
• ECURH20M1000: Device Name: OSBONE® DENTAL lndications for Use: OSBONE® DENTAL is intended for the filling a
• ECURH10V1000: Device Name: OSBONE® DENTAL lndications for Use: OSBONE® DENTAL is intended for the filling a
• ECURH10V0250: Device Name: OSBONE® DENTAL lndications for Use: OSBONE® DENTAL is intended for the filling a
• ECURH10M1000: Device Name: OSBONE® DENTAL lndications for Use: OSBONE® DENTAL is intended for the filling a
• ECURH10M0250: Device Name: OSBONE® DENTAL lndications for Use: OSBONE® DENTAL is intended for the filling a
• ECURH05V1000: Device Name: OSBONE® DENTAL lndications for Use: OSBONE® DENTAL is intended for the filling a
• ECURH05V0250: Device Name: OSBONE® DENTAL lndications for Use: OSBONE® DENTAL is intended for the filling
• ECURH05M1000: Device Name: OSBONE® DENTAL lndications for Use: OSBONE® DENTAL is intended for the filling a
• ECURH05M0250: Device Name: OSBONE® DENTAL lndications for Use: OSBONE® DENTAL is intended for the filling