Elos Accurate Hybrid Base H Non-Engaging

GUDID 05712821007100

Base is a titanium base designed to interface with a dental implant and to support a patient-specific ceramic superstructure or a multi-unit direct restoration cemented to the base. The base and the superstructure form a patient-specific abutment that will support a definitive restoration, either a single crown or a multi-unit restoration. The Elos Accurate Hybrid Base Engaging is intended for single-unit restorations and Elos Accurate Hybrid Base Nonengaging is intended for multi-unit restorations. Alternatively, a definitive multi-unit restoration may be cemented directly to the Elos Accurate Hybrid Base.

Elos Medtech Pinol A/S

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 05712821007100
• NIH Device Record Key: b2f10ad2-1b5f-4203-b374-60bb97663650
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Elos Accurate Hybrid Base H Non-Engaging
• Version Model Number: HBN-BRA35H-1
• Company DUNS: 306155953
• Company Name: Elos Medtech Pinol A/S
• 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	05712821007100 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201860

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

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

[05712821007100]

Moist Heat or Steam Sterilization

[05712821007100]

Moist Heat or Steam Sterilization

[05712821007100]

Moist Heat or Steam Sterilization

[05712821007100]

Moist Heat or Steam Sterilization

[05712821007100]

Moist Heat or Steam Sterilization

[05712821007100]

Moist Heat or Steam Sterilization

[05712821007100]

Moist Heat or Steam Sterilization

[05712821007100]

Moist Heat or Steam Sterilization

[05712821007100]

Moist Heat or Steam Sterilization

[05712821007100]

Moist Heat or Steam Sterilization

[05712821007100]

Moist Heat or Steam Sterilization

[05712821007100]

Moist Heat or Steam Sterilization

[05712821007100]

Moist Heat or Steam Sterilization

[05712821007100]

Moist Heat or Steam Sterilization

[05712821007100]

Moist Heat or Steam Sterilization

[05712821007100]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-10-28
• Device Publish Date: 2021-10-20

On-Brand Devices [Elos Accurate Hybrid Base H Non-Engaging]

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• 05712821007193: The Elos Accurate Hybrid Base is a titanium base designed to interface with a dental implant and
• 05712821007186: Base is a titanium base designed to interface with a dental implant and to support a patient-spe
• 05712821007179: Base is a titanium base designed to interface with a dental implant and to support a patient-spe
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• 05712821007100: Base is a titanium base designed to interface with a dental implant and to support a patient-spe
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• 05712821008251: The Elos Accurate Hybrid Base is a titanium base designed to interface with a dental implant and
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• 05712821013644: The Elos Accurate Hybrid Base is a titanium base designed to interface with a dental implant and
• 05712821013637: The Elos Accurate Hybrid Base is a titanium base designed to interface with a dental implant and