Restore Implant System TS3813K

GUDID D768TS3813K0

Implant

KEYSTONE DENTAL, INC.

Screw endosteal dental implant, two-piece

• Primary Device ID: D768TS3813K0
• NIH Device Record Key: 78688462-ab4f-4e2d-b498-1aa38f4f9019
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Restore Implant System
• Version Model Number: TS3813K
• Catalog Number: TS3813K
• 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
• 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 Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D768TS3813K0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K950624

FDA Product Code

• DZE: IMPLANT, ENDOSSEOUS, ROOT-FORM

Sterilization

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

[D768TS3813K0]

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: 2016-01-29

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