OCTAGON Infinity BL NC Basic screw, L 7.85 mm 5022030

GUDID E0HM50220301

BL NC Basic screw, L 7.85 mm for OCTAGON Infinity Dental Implant BL NC

Hager & Meisinger Gesellschaft mit beschränkter Haftung

Dental implant suprastructure, permanent, preformed

• Primary Device ID: E0HM50220301
• NIH Device Record Key: 5233715b-386f-4cde-aaa5-4b3728ef506c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OCTAGON Infinity BL NC Basic screw, L 7.85 mm
• Version Model Number: 5022030
• Catalog Number: 5022030
• 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
• 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	E0HM50220301 [Primary]
HIBCC	XXXX50220309 [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

[E0HM50220301]

Moist Heat or Steam Sterilization

[E0HM50220301]

Moist Heat or Steam Sterilization

[E0HM50220301]

Moist Heat or Steam Sterilization

[E0HM50220301]

Moist Heat or Steam Sterilization

[E0HM50220301]

Moist Heat or Steam Sterilization

[E0HM50220301]

Moist Heat or Steam Sterilization

[E0HM50220301]

Moist Heat or Steam Sterilization

[E0HM50220301]

Moist Heat or Steam Sterilization

[E0HM50220301]

Moist Heat or Steam Sterilization

[E0HM50220301]

Moist Heat or Steam Sterilization

[E0HM50220301]

Moist Heat or Steam Sterilization

[E0HM50220301]

Moist Heat or Steam Sterilization

[E0HM50220301]

Moist Heat or Steam Sterilization

[E0HM50220301]

Moist Heat or Steam Sterilization

[E0HM50220301]

Moist Heat or Steam Sterilization

[E0HM50220301]

Moist Heat or Steam Sterilization

[E0HM50220301]

Moist Heat or Steam Sterilization

[E0HM50220301]

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: 2016-09-09

On-Brand Devices [OCTAGON Infinity BL NC Basic screw, L 7.85 mm]

• E0HM50220431: BL NC Basic screw, L 7.85 mm for OCTAGON Infinity Dental Implant BL NC
• E0HM50220301: BL NC Basic screw, L 7.85 mm for OCTAGON Infinity Dental Implant BL NC