Instradent XenoGraft

Basic Information

• Brand Name: Instradent XenoGraft
• Primary DI: 08809186540551
• Version / Model: I1-1020-200
• Company Name: Nibec Co., Ltd.
• Labeler DUNS: 687796909
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-23
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 38cba24f-bce6-4544-a176-c56abd0bd3db

Device Description

Instradent XenoGraft is a sterile, porous bone mineral matrix produced by the removal of the organic compounds from bovine bone. The Instradent XenoGraft contains pure hydroxyapatite derived from bovine bone using a validated the manufacturing process. The large surface area of Instradent XenoGraft is effective for the regeneration of new bone around the grafted bone. The Instradent XenoGraft has good osteoconductivity to enhance new bone formation.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NPM	Bone Grafting Material, Animal Source	Dental	872.3930	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47968	Dental bone matrix implant, animal-derived	A sterile bioabsorbable device made primarily of animal-derived bone or dentin matrix (e.g., bovine, porcine) implanted into the body to provide osteoconductive bone-tissue scaffolds to replace maxillofacial and/or mandibular bone lost through trauma or dental surgery. It is used to fill bone cavities and defects and contains pores that promote the ingrowth of endogenous bone for skeletal reconstruction and/or augmentation. It is typically provided as sterile cancellous blocks, chips, or granules of varying sizes, or mouldable materials.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08809186540551	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K113246	000

Device Sizes

Type	Value	Unit	Text
Weight	2	Gram

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 15 – 25 Degrees Celsius