Renova

GUDID D76843103K0

Snap Abutment

KEYSTONE DENTAL, INC.

Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed

• Primary Device ID: D76843103K0
• NIH Device Record Key: c9ea9f75-5604-4cb1-a836-a1a8fcdbf1e6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Renova
• Version Model Number: 43103K
• Company DUNS: 787471015
• Company Name: KEYSTONE DENTAL, INC.
• Device Count: 1
• DM Exempt: false
• 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(999)999-9999
• 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 Identifiers

Device Issuing Agency	Device ID
HIBCC	D76843103K0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K032774

FDA Product Code

• NHA: ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS

Sterilization

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

[D76843103K0]

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: 2017-05-30

On-Brand Devices [Renova]

• D76843121K0: Fixed Detach Abutment
• D76843120K0: Fixed Detach Abutment
• D76843119K0: Fixed Detach Abutment
• D76843118K0: Fixed Detach Abutment
• D76843116K0: Abutment Screw
• D76843114K0: UCLA Abutment
• D76843113K0: UCLA Abutment
• D76843111K0: UCLA Abutment
• D76843110K0: UCLA Abutment
• D76843109K0: Snap Abutment
• D76843108K0: Snap Abutment
• D76843107K0: Snap Abutment
• D76843106K0: Snap Abutment
• D76843105K0: Snap Abutment
• D76843104K0: Snap Abutment
• D76843103K0: Snap Abutment
• D76843102K0: Snap Abutment
• D76843100K0: Abutment Screw
• D76843096K0: COC Abutment
• D76843094K0: COC Abutment
• D76843092K0: COC Abutment
• D76843090K0: COC Abutment
• D76843089K0: COC Abutment
• D76843010K0: Sleeve w/screw
• D76843009K0: Sleeve w/screw
• D76843007K0: Sleeve w/screw
• D76843006K0: Sleeve w/screw
• D76810040K0: Healing Abutment
• D76810039K0: Healing Abutment
• D76810038K0: Healing Abutment
• D76810037K0: Healing Abutment
• D76810036K0: Healing Abutment
• D76810035K0: Healing Abutment
• D76810033K0: Cover Screw
• D76810032K0: Cover Screw