OCTAGON Infinity BL NC ALLIGATOR Abutment GH 5.0 mm 5022039

GUDID E0HM50220391

BL NC ALLIGATOR Abutment GH 5.0 mm for OCTAGON Infinity Dental Implant BL NC

Hager & Meisinger Gesellschaft mit beschränkter Haftung

Dental implant suprastructure, permanent, preformed

• Primary Device ID: E0HM50220391
• NIH Device Record Key: b2cb964d-a071-4f07-92bd-4a56fdfe2f4c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OCTAGON Infinity BL NC ALLIGATOR Abutment GH 5.0 mm
• Version Model Number: 5022039
• Catalog Number: 5022039
• Company DUNS: 318034329
• Company Name: Hager & Meisinger Gesellschaft mit beschränkter Haftung
• 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: 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: +1(508)588-3100
• Email: kathystrange@acesurgical.com
• Phone: +1(508)588-3100
• Email: kathystrange@acesurgical.com
• Phone: +1(508)588-3100
• Email: kathystrange@acesurgical.com
• Phone: +1(508)588-3100
• Email: kathystrange@acesurgical.com
• Phone: +1(508)588-3100
• Email: kathystrange@acesurgical.com
• Phone: +1(508)588-3100
• Email: kathystrange@acesurgical.com
• Phone: +1(508)588-3100
• Email: kathystrange@acesurgical.com
• Phone: +1(508)588-3100
• Email: kathystrange@acesurgical.com
• Phone: +1(508)588-3100
• Email: kathystrange@acesurgical.com
• Phone: +1(508)588-3100
• Email: kathystrange@acesurgical.com
• Phone: +1(508)588-3100
• Email: kathystrange@acesurgical.com
• Phone: +1(508)588-3100
• Email: kathystrange@acesurgical.com
• Phone: +1(508)588-3100
• Email: kathystrange@acesurgical.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	E0HM50220391 [Primary]
HIBCC	E0HM50220399 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K143539

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

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

[E0HM50220391]

Moist Heat or Steam Sterilization

[E0HM50220391]

Moist Heat or Steam Sterilization

[E0HM50220391]

Moist Heat or Steam Sterilization

[E0HM50220391]

Moist Heat or Steam Sterilization

[E0HM50220391]

Moist Heat or Steam Sterilization

[E0HM50220391]

Moist Heat or Steam Sterilization

[E0HM50220391]

Moist Heat or Steam Sterilization

[E0HM50220391]

Moist Heat or Steam Sterilization

[E0HM50220391]

Moist Heat or Steam Sterilization

[E0HM50220391]

Moist Heat or Steam Sterilization

[E0HM50220391]

Moist Heat or Steam Sterilization

[E0HM50220391]

Moist Heat or Steam Sterilization

[E0HM50220391]

Moist Heat or Steam 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: 2016-12-06

On-Brand Devices [OCTAGON Infinity BL NC ALLIGATOR Abutment GH 5.0 mm]

• XXXX50220399: BL NC ALLIGATOR Abutment GH 5.0 mm for OCTAGON Infinity Dental Implant BL NC
• E0HM50220391: BL NC ALLIGATOR Abutment GH 5.0 mm for OCTAGON Infinity Dental Implant BL NC