Genesis Implant System G21135

GUDID D768G211350

Implant

KEYSTONE DENTAL, INC.

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• Primary Device ID: D768G211350
• NIH Device Record Key: 1cbb891c-22d9-432a-8da1-ee7fb7c5265b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Genesis Implant System
• Version Model Number: G21135
• Catalog Number: G21135
• 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(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 Identifiers

Device Issuing Agency	Device ID
HIBCC	D768G211350 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K101545

FDA Product Code

• DZE: IMPLANT, ENDOSSEOUS, ROOT-FORM

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2021-03-31
• Device Publish Date: 2016-01-29

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• D768G211510: Implant
• D768G211500: Implant
• D768G211470: Implant
• D768G211460: Implant
• D768G211450: Implant
• D768G211440: Implant
• D768G211420: Implant
• D768G211400: Implant
• D768G211390: Implant
• D768G211380: Implant
• D768G211370: Implant
• D768G211350: Implant
• D768G211330: Implant
• D768G211320: Implant
• D768G211310: Implant
• D768G211300: Implant
• D768G210530: Implant
• D768G210520: Implant
• D768G210510: Implant
• D768G210500: Implant