Sustain 410240-42-04K

GUDID D7684102404204K0

Fixed Detach Abutment

KEYSTONE DENTAL, INC.

Dental implant suprastructure, permanent, preformed

• Primary Device ID: D7684102404204K0
• NIH Device Record Key: aef423b2-aaf2-4b31-bbf5-16c0aa89e1b5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sustain
• Version Model Number: 410240-42-04K
• Catalog Number: 410240-42-04K
• 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	D7684102404204K0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K002037

FDA Product Code

• NHA: ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS

Sterilization

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

[D7684102404204K0]

Radiation Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-11-08
• Device Publish Date: 2016-02-04

On-Brand Devices [Sustain]

• D7684107204K0: Gold Sleeve
• D768410475340K0: Snap Abutment
• D768410475320K0: Snap Abutment
• D768410440330K0: Fixed Detach Abutment
• D7684102404204K0: Fixed Detach Abutment
• D7684102403404K0: Fixed Detach Abutment
• D7684102403402K0: Fixed Detach Abutment
• D7684102004730K0: Fixed Detach Abutment
• D7684102003330K0: Fixed Detach Abutment
• D76841060545K0: Healing Abutment
• D76841060535K0: Healing Abutment