Tri-Nex Implant System IA-LH-50-16

GUDID D768IALH50160

Implant

KEYSTONE DENTAL, INC.

Screw endosteal dental implant, two-piece

• Primary Device ID: D768IALH50160
• NIH Device Record Key: 287b0284-f0dd-4452-8503-55ba45ea733f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tri-Nex Implant System
• Version Model Number: IA-LH-50-16
• Catalog Number: IA-LH-50-16
• 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	D768IALH50160 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K070905

FDA Product Code

• DZE: IMPLANT, ENDOSSEOUS, ROOT-FORM

Sterilization

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

[D768IALH50160]

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 [Tri-Nex Implant System]

• D768TRIMAX990: Implant
• D768TRIMAX970: Implant
• D768TRIMAX9110: Implant
• D768TRIMAX890: Implant
• D768TRIMAX870: Implant
• D768TRIMAX8110: Implant
• D768TRIMAX790: Implant
• D768TRIMAX770: Implant
• D768TRIMAX7110: Implant
• D768IALH6080: Implant
• D768IALH60160: Implant
• D768IALH60130: Implant
• D768IALH601150: Implant
• D768IALH60100: Implant
• D768IALH5080: Implant
• D768IALH50160: Implant
• D768IALH50130: Implant
• D768IALH501150: Implant
• D768IALH50100: Implant
• D768IALH4380: Implant
• D768IALH43160: Implant
• D768IALH43130: Implant
• D768IALH431150: Implant
• D768IALH43100: Implant
• D768IALH3580: Implant
• D768IALH35160: Implant
• D768IALH35130: Implant
• D768IALH351150: Implant
• D768IALH35100: Implant
• D768IA5012D160: Implant
• D768IA5012D130: Implant
• D768IA5012D1150: Implant
• D768IA5012D100: Implant
• D768IA4312D160: Implant
• D768IA4312D130: Implant
• D768IA4312D1150: Implant
• D768IA4312D100: Implant