DynaGraft D

Basic Information

• Brand Name: DynaGraft D
• Primary DI: D7681012010700
• Version / Model: 10.120.1070
• Catalog Number: 10.120.1070
• Company Name: KEYSTONE DENTAL, INC.
• Labeler DUNS: 787471015
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-02-04
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: ac7a7f20-f2b1-4a81-92d8-e0dc2b6f2b78

Device Description

Biomaterials

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: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: Yes
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: Yes
• Sterilization Methods: Radiation Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NUN	BONE GRAFTING MATERIAL, HUMAN SOURCE	Dental	872.3930	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47970	Dental bone matrix implant, human-derived	A sterile implantable device made primarily of human demineralized bone matrix (DBM) (acid extraction of allogeneic bone resulting in loss of most of the mineralized component but retention of proteins) intended to augment/reconstruct maxillofacial and/or mandibular bone by filling bone voids or gaps caused by trauma or dental surgery. It is bioabsorbable, osteoconductive, and has demonstrated at least potential osteoinductivity for stimulation of new bone growth. The DBM may be combined with various carrier compounds (e.g., gelatin, hydrogel, starch) or other materials. It is typically available in the form of a sterile powder, crushed granules, putty, chips, or gel injected with syringe.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	D7681012010700	HIBCC

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K043573	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			.5cc - 5cc