AccessGUDID - DEVICE: Osbone Dental (ECURH10M0250)

GUDID

Device Identifier (DI) Information

Brand Name: Osbone Dental
Version or Model: 250-1000µm
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 5 x 1.0 cc
Company Name: curasan AG

Primary DI Number: ECURH10M0250
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 5
Labeler D-U-N-S® Number*: 324331826 *Terms of Use

Device Description: 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

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
16966	Synthetic bone graft	An artificial bone substitute used for structural bone replacement typically when bone is lost due to disease (e.g., osteoporosis) or injury. It consists mainly of porous and mesh ceramic materials that provide a framework for bone growth, or harvested sea coral that serves as an additive, extender, or provides a framework for bone growth. This is a single-use device.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
LYC	Bone Grafting Material, Synthetic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K102872	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 1.0 Centiliter

Device Record Status

Public Device Record Key: 3a933a9e-130f-4735-94b8-80e6e4ba9256
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: February 11, 2017