Cagenix AccuFrame

GUDID 90860002441903

Titanium framework for supporting multi implant restorations

CAGENIX, INC.

Dental implant suprastructure, permanent, custom-made

• Primary Device ID: 90860002441903
• NIH Device Record Key: 85f33acf-9579-4ff5-b0cf-765487f96850
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cagenix AccuFrame
• Version Model Number: 1000-01
• Company DUNS: 030868250
• Company Name: CAGENIX, 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: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 9017633784
• Email: ajschulter@cagenix.com
• Phone: 9017633784
• Email: ajschulter@cagenix.com
• Phone: 9017633784
• Email: ajschulter@cagenix.com
• Phone: 9017633784
• Email: ajschulter@cagenix.com
• Phone: 9017633784
• Email: ajschulter@cagenix.com
• Phone: 9017633784
• Email: ajschulter@cagenix.com
• Phone: 9017633784
• Email: ajschulter@cagenix.com
• Phone: 9017633784
• Email: ajschulter@cagenix.com
• Phone: 9017633784
• Email: ajschulter@cagenix.com
• Phone: 9017633784
• Email: ajschulter@cagenix.com
• Phone: 9017633784
• Email: ajschulter@cagenix.com
• Phone: 9017633784
• Email: ajschulter@cagenix.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	90860002441903 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K081157

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

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

[90860002441903]

Moist Heat or Steam Sterilization

[90860002441903]

Moist Heat or Steam Sterilization

[90860002441903]

Moist Heat or Steam Sterilization

[90860002441903]

Moist Heat or Steam Sterilization

[90860002441903]

Moist Heat or Steam Sterilization

[90860002441903]

Moist Heat or Steam Sterilization

[90860002441903]

Moist Heat or Steam Sterilization

[90860002441903]

Moist Heat or Steam Sterilization

[90860002441903]

Moist Heat or Steam Sterilization

[90860002441903]

Moist Heat or Steam Sterilization

[90860002441903]

Moist Heat or Steam Sterilization

[90860002441903]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-07-24
• Device Publish Date: 2020-07-16

Devices Manufactured by CAGENIX, INC.

• 90860002441903 - Cagenix AccuFrame: 2020-07-24Titanium framework for supporting multi implant restorations
• 90860002441903 - Cagenix AccuFrame: 2020-07-24 Titanium framework for supporting multi implant restorations
• 90860002441910 - Cagenix AccuFrame IC: 2020-07-24 AccuFrame Titanium Framework to support a series of individual crowns
• 90860002441927 - Cagenix AccuFrame 360: 2020-07-24 AccuFrame Titanium Framework to support milled overlay
• 90860002441934 - Cagenix AccuFrame Overdenture: 2020-07-24 AccuFrame Titanium Framework to support milled overdenture
• 90860002441941 - Cagenix BarZero: 2020-07-24 Milled denture teeth for dental restoration