OKTAGON BL NC/RC ALLIGATOR Basic Screw (22041/22042/22129/22130) 22131

GUDID EDRS221311

BL NC/RC ALLIGATOR Basic Screw (22041/22042/22129/22130) for OKTAGON Dental Implant BL RC

Hager & Meisinger Gesellschaft mit beschränkter Haftung

Dental implant suprastructure, permanent, preformed

• Primary Device ID: EDRS221311
• NIH Device Record Key: 44ecdbbe-a228-4ad5-8582-1d5ae86de2cf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OKTAGON BL NC/RC ALLIGATOR Basic Screw (22041/22042/22129/22130)
• Version Model Number: 22131
• Catalog Number: 22131
• 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: +492173398000
• Email: info@dental-ratio.de
• Phone: +492173398000
• Email: info@dental-ratio.de
• Phone: +492173398000
• Email: info@dental-ratio.de
• Phone: +492173398000
• Email: info@dental-ratio.de
• Phone: +492173398000
• Email: info@dental-ratio.de
• Phone: +492173398000
• Email: info@dental-ratio.de
• Phone: +492173398000
• Email: info@dental-ratio.de
• Phone: +492173398000
• Email: info@dental-ratio.de
• Phone: +492173398000
• Email: info@dental-ratio.de
• Phone: +492173398000
• Email: info@dental-ratio.de

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	EDRS221311 [Primary]
HIBCC	EDRS221319 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160132

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

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

[EDRS221311]

Moist Heat or Steam Sterilization

[EDRS221311]

Moist Heat or Steam Sterilization

[EDRS221311]

Moist Heat or Steam Sterilization

[EDRS221311]

Moist Heat or Steam Sterilization

[EDRS221311]

Moist Heat or Steam Sterilization

[EDRS221311]

Moist Heat or Steam Sterilization

[EDRS221311]

Moist Heat or Steam Sterilization

[EDRS221311]

Moist Heat or Steam Sterilization

[EDRS221311]

Moist Heat or Steam Sterilization

[EDRS221311]

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: 2017-01-24

On-Brand Devices [OKTAGON BL NC/RC ALLIGATOR Basic Screw (22041/22042/22129/22130)]

• EDRS221311: BL NC/RC ALLIGATOR Basic Screw (22041/22042/22129/22130) for OKTAGON Dental Implant BL RC
• E0HM221311: BL NC/RC ALLIGATOR Basic Screw (22041/22042/22129/22130) for OKTAGON Dental Implant BL RC