Renova 43094K

GUDID D76843094K0

COC Abutment

KEYSTONE DENTAL, INC.

Dental implant suprastructure, permanent, preformed

• Primary Device ID: D76843094K0
• NIH Device Record Key: bd79c3ff-d193-43c5-9b74-91220f12b442
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Renova
• Version Model Number: 43094K
• Catalog Number: 43094K
• 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	D76843094K0 [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

[D76843094K0]

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 [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