Oct Implant System ITC408

GUDID D768ITC4080

Implant

KEYSTONE DENTAL, INC.

Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece

• Primary Device ID: D768ITC4080
• NIH Device Record Key: e0e8469f-9dc2-455d-b77d-8f5c29833c34
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Oct Implant System
• Version Model Number: ITC408
• Catalog Number: ITC408
• Company DUNS: 787471015
• Company Name: KEYSTONE DENTAL, INC.
• Device Count: 1
• DM Exempt: true
• 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: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(781)328-3515
• Email: cyoung@keystonedental.com
• Phone: +1(866)902-9272
• Email: info@keystonedental.com
• Phone: +1(866)902-9272
• Email: info@keystonedental.com
• Phone: +1(866)902-9272
• Email: info@keystonedental.com
• Phone: +1(866)902-9272
• Email: info@keystonedental.com
• Phone: +1(866)902-9272
• Email: info@keystonedental.com
• Phone: +1(866)902-9272
• Email: info@keystonedental.com
• Phone: +1(866)902-9272
• Email: info@keystonedental.com
• Phone: +1(866)902-9272
• Email: info@keystonedental.com
• Phone: +1(866)902-9272
• Email: info@keystonedental.com
• Phone: +1(866)902-9272
• Email: info@keystonedental.com
• Phone: +1(866)902-9272
• Email: info@keystonedental.com
• Phone: +1(866)902-9272
• Email: info@keystonedental.com
• Phone: +1(866)902-9272
• Email: info@keystonedental.com
• Phone: +1(866)902-9272
• Email: info@keystonedental.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D768ITC4080 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K061169

FDA Product Code

• DZE: IMPLANT, ENDOSSEOUS, ROOT-FORM

Sterilization

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

[D768ITC4080]

Radiation Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-02-04

On-Brand Devices [Oct Implant System]

• D768MAXIT990: Implant
• D768MAXIT970: Implant
• D768MAXIT9110: Implant
• D768MAXIT890: Implant
• D768MAXIT870: Implant
• D768MAXIT8110: Implant
• D768MAXIT790: Implant
• D768MAXIT770: Implant
• D768MAXIT7110: Implant
• D768ITT6120: Implant
• D768ITT6100: Implant
• D768ITT6080: Implant
• D768ITT5140: Implant
• D768ITT5120: Implant
• D768ITT5100: Implant
• D768ITT5080: Implant
• D768ITT4140: Implant
• D768ITT4120: Implant
• D768ITT4100: Implant
• D768ITT4080: Implant
• D768ITST12D5140: Implant
• D768ITST12D5120: Implant
• D768ITST12D5100: Implant
• D768ITST12D5080: Implant
• D768ITC5140: Implant
• D768ITC5120: Implant
• D768ITC5100: Implant
• D768ITC5080: Implant
• D768ITC5060: Implant
• D768ITC4140: Implant
• D768ITC4120: Implant
• D768ITC4100: Implant
• D768ITC4080: Implant
• D768ITC4060: Implant
• D768ITC3140: Implant
• D768ITC3120: Implant
• D768ITC3100: Implant
• D768ITC3080: Implant
• D768ITC3060: Implant