i-Gen

Basic Information

• Brand Name: i-Gen
• Primary DI: 08806388221691
• Version / Model: IG2W0918
• Catalog Number: IG2W0918
• Company Name: Megagen Implant Co. Ltd
• Labeler DUNS: 687388178
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-06-25
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: f804517a-d729-46d5-969a-7376b1370d03

Device Description

i-Gen Type B1

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: Yes
• 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
JEY	Plate, Bone	Dental	872.4760	2

GMDN Terms

Code	Name	Definition	Implantable	Status
48004	Dental bone matrix implant, metallic	A sterile non-bioabsorbable device made of metal and/or metal oxide [e.g., titanium (Ti)] 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 typically used to fill bone cavities and defects to promote the ingrowth of endogenous bone for skeletal reconstruction and/or augmentation. It is typically available as porous granules.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08806388221691	GS1

Premarket Submissions

Submission Number	Supplement Number
K131289	000