Argen AG61.087

GUDID 08435457275350

BioHorizons® Internal

TERRATS MEDICAL SL.

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 08435457275350
• NIH Device Record Key: fd91e70a-f3af-40b6-96ce-da2aa31bbae0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Argen
• Version Model Number: 61.087
• Catalog Number: AG61.087
• Company DUNS: 769461323
• Company Name: TERRATS MEDICAL SL.
• 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: +34935646006
• Email: orders@dessdental.com
• Phone: +34935646006
• Email: orders@dessdental.com
• Phone: +34935646006
• Email: orders@dessdental.com
• Phone: +34935646006
• Email: orders@dessdental.com
• Phone: +34935646006
• Email: orders@dessdental.com
• Phone: +34935646006
• Email: orders@dessdental.com
• Phone: +34935646006
• Email: orders@dessdental.com
• Phone: +34935646006
• Email: orders@dessdental.com
• Phone: +34935646006
• Email: orders@dessdental.com
• Phone: +34935646006
• Email: orders@dessdental.com
• Phone: +34935646006
• Email: orders@dessdental.com
• Phone: +34935646006
• Email: orders@dessdental.com
• Phone: +34935646006
• Email: orders@dessdental.com
• Phone: +34935646006
• Email: orders@dessdental.com
• Phone: +34935646006
• Email: orders@dessdental.com
• Phone: +34935646006
• Email: orders@dessdental.com
• Phone: +34935646006
• Email: orders@dessdental.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	08435457275350 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K212628

FDA Product Code

• NHA: Abutment, implant, dental, endosseous

Sterilization

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

[08435457275350]

Moist Heat or Steam Sterilization

[08435457275350]

Moist Heat or Steam Sterilization

[08435457275350]

Moist Heat or Steam Sterilization

[08435457275350]

Moist Heat or Steam Sterilization

[08435457275350]

Moist Heat or Steam Sterilization

[08435457275350]

Moist Heat or Steam Sterilization

[08435457275350]

Moist Heat or Steam Sterilization

[08435457275350]

Moist Heat or Steam Sterilization

[08435457275350]

Moist Heat or Steam Sterilization

[08435457275350]

Moist Heat or Steam Sterilization

[08435457275350]

Moist Heat or Steam Sterilization

[08435457275350]

Moist Heat or Steam Sterilization

[08435457275350]

Moist Heat or Steam Sterilization

[08435457275350]

Moist Heat or Steam Sterilization

[08435457275350]

Moist Heat or Steam Sterilization

[08435457275350]

Moist Heat or Steam Sterilization

[08435457275350]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-05-05
• Device Publish Date: 2023-04-27

On-Brand Devices [Argen]

• 08435457279242: AstraTech EV®
• 08435457279235: Neodent®
• 08435457275404: Straumann BLX®
• 08435457275381: BioHorizons® Internal
• 08435457275374: BioHorizons® Internal
• 08435457275367: BioHorizons® Internal
• 08435457275350: BioHorizons® Internal
• 08435457275343: Osstem®TS / Hiossen® ET
• 08435457275336: Osstem®TS / Hiossen® ET
• 08435457275275: Straumann BLX®
• 08435457275268: AstraTech EV®
• 08435457275251: AstraTech EV®
• 08435457275244: AstraTech EV®
• 08435457275220: Straumann Synocta®
• 08435457275183: Neodent®
• 08435457275169: Biomet 3i Certain®
• 08435457275152: Biomet 3i Certain®
• 08435457275121: Nobel Replace®
• 08435457275114: Nobel Replace®
• 08435457275107: Nobel Branemark®
• 08435457272069: Nobel Replace®
• 08435750411073: Nobel Replace®
• 08435750410724: Straumann Bone Level®
• 08435750410717: Nobel Active®
• 08435750410700: Nobel Replace®
• 08435750410694: Nobel Replace®
• 08435750410687: Nobel Replace®
• 08435750410670: Nobel Replace®
• 08435750410663: Nobel Replace®
• 08435750411882: Multiunit
• 08435750411875: Multiunit