i-Gen Cover Screw ICS3510

GUDID 08806388220441

Common Ø3.5/ H=1

Megagen Implant Co. Ltd

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 08806388220441
• NIH Device Record Key: 80af291c-d496-4871-873a-405b698f5459
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: i-Gen Cover Screw
• Version Model Number: ICS3510
• Catalog Number: ICS3510
• Company DUNS: 687388178
• Company Name: Megagen Implant Co. Ltd
• 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: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08806388220441 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150537

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-11-08
• Device Publish Date: 2015-07-27

On-Brand Devices [i-Gen Cover Screw]

• 08806388220441: Common Ø3.5/ H=1
• 08806388220434: Common Ø3.5/ H=0.5