Azure ARBHI-TBASNH35

GUDID 08435457288305

Internal Hex BH

TERRATS MEDICAL SL.

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 08435457288305
• NIH Device Record Key: 11d09d7c-ba75-4c4f-b788-1212d111d99e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Azure
• Version Model Number: 36.087
• Catalog Number: ARBHI-TBASNH35
• 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@dess-abutments.com
• Phone: +34935646006
• Email: orders@dess-abutments.com
• Phone: +34935646006
• Email: orders@dess-abutments.com
• Phone: +34935646006
• Email: orders@dess-abutments.com
• Phone: +34935646006
• Email: orders@dess-abutments.com
• Phone: +34935646006
• Email: orders@dess-abutments.com
• Phone: +34935646006
• Email: orders@dess-abutments.com
• Phone: +34935646006
• Email: orders@dess-abutments.com
• Phone: +34935646006
• Email: orders@dess-abutments.com
• Phone: +34935646006
• Email: orders@dess-abutments.com
• Phone: +34935646006
• Email: orders@dess-abutments.com
• Phone: +34935646006
• Email: orders@dess-abutments.com
• Phone: +34935646006
• Email: orders@dess-abutments.com
• Phone: +34935646006
• Email: orders@dess-abutments.com
• Phone: +34935646006
• Email: orders@dess-abutments.com
• Phone: +34935646006
• Email: orders@dess-abutments.com
• Phone: +34935646006
• Email: orders@dess-abutments.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	08435457288305 [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

[08435457288305]

Moist Heat or Steam Sterilization

[08435457288305]

Moist Heat or Steam Sterilization

[08435457288305]

Moist Heat or Steam Sterilization

[08435457288305]

Moist Heat or Steam Sterilization

[08435457288305]

Moist Heat or Steam Sterilization

[08435457288305]

Moist Heat or Steam Sterilization

[08435457288305]

Moist Heat or Steam Sterilization

[08435457288305]

Moist Heat or Steam Sterilization

[08435457288305]

Moist Heat or Steam Sterilization

[08435457288305]

Moist Heat or Steam Sterilization

[08435457288305]

Moist Heat or Steam Sterilization

[08435457288305]

Moist Heat or Steam Sterilization

[08435457288305]

Moist Heat or Steam Sterilization

[08435457288305]

Moist Heat or Steam Sterilization

[08435457288305]

Moist Heat or Steam Sterilization

[08435457288305]

Moist Heat or Steam Sterilization

[08435457288305]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-09-13
• Device Publish Date: 2023-09-05

On-Brand Devices [Azure]

• 08435750402484: Internal ANK
• 08435750402415: Conic OSS
• 08435750402408: Conic OSS
• 08435750402392: Internal CAM
• 08435750402385: Internal CAM
• 08435750402378: Conic EVO
• 08435750402361: Conic EVO
• 08435750402347: Internal ANK
• 08435750402323: Active Hex
• 08435750402316: Active Hex
• 08435750402309: Internal Hex FD
• 08435750402293: Internal Hex FD
• 08435750402286: Internal Hex FD
• 08435750402279: Internal Hex Conic
• 08435750402262: Internal Hex Conic
• 08435750402255: Internal Hex USA
• 08435750402248: Internal Hex USA
• 08435750402231: Internal Hex "Click"
• 08435750402224: Internal Hex "Click"
• 08435750402217: External Hex USA
• 08435750402200: External Hex USA
• 08435750402194: External Hex USA
• 08435750402170: Tri-lobe
• 08435750402163: Tri-lobe
• 08435750402156: External Hex Universal
• 08435750402149: External Hex Universal
• 08435750402132: Internal ANK
• 08435750402040: Conic OSS
• 08435750402033: Conic OSS
• 08435750402026: Internal CAM
• 08435750402019: Internal CAM
• 08435750402002: Conic EVO
• 08435750401999: Conic EVO
• 08435750401982: Conic EVO
• 08435750401968: Multiunit
• 08435750401951: Internal ANK
• 08435750401937: Octagon
• 08435750401920: Active Hex
• 08435750401913: Active Hex
• 08435750401906: Internal Hex FD
• 08435750401890: Internal Hex FD
• 08435750401883: Internal Hex FD
• 08435750401852: Internal Hex Conic
• 08435750401845: Internal Hex Conic
• 08435750401838: Internal Hex USA
• 08435750401821: Internal Hex USA
• 08435750401814: Internal Hex USA
• 08435750401807: Internal Hex "Click"
• 08435750401791: Internal Hex "Click"
• 08435750401784: Internal Hex "Click"