Elos Accurate® Hybrid Base™ Engaging

GUDID 05712821000354

The Elos Accurate Hybrid 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: 05712821000354
• NIH Device Record Key: 1d79ad6e-7449-4163-8bcb-45d419913c68
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Elos Accurate® Hybrid Base™ Engaging
• Version Model Number: HBE-NBA35-1
• 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	05712821000354 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191919

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

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

[05712821000354]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-04-08
• Device Publish Date: 2020-03-31

On-Brand Devices [Elos Accurate® Hybrid Base™ Engaging ]

• 05712821000545: The Elos Accurate Hybrid Base is a titanium base designed to interface with a dental implant and
• 05712821000538: The Elos Accurate Hybrid Base is a titanium base designed to interface with a dental implant and
• 05712821000521: The Elos Accurate Hybrid Base is a titanium base designed to interface with a dental implant and
• 05712821000514: The Elos Accurate Hybrid Base is a titanium base designed to interface with a dental implant and
• 05712821000507: The Elos Accurate Hybrid Base is a titanium base designed to interface with a dental implant and
• 05712821000491: The Elos Accurate Hybrid Base is a titanium base designed to interface with a dental implant and
• 05712821000484: The Elos Accurate Hybrid Base is a titanium base designed to interface with a dental implant and
• 05712821000477: The Elos Accurate Hybrid Base is a titanium base designed to interface with a dental implant and
• 05712821000439: The Elos Accurate Hybrid Base is a titanium base designed to interface with a dental implant and
• 05712821000422: The Elos Accurate Hybrid Base is a titanium base designed to interface with a dental implant and
• 05712821000415: The Elos Accurate Hybrid Base is a titanium base designed to interface with a dental implant and
• 05712821000408: The Elos Accurate Hybrid Base is a titanium base designed to interface with a dental implant and
• 05712821000392: The Elos Accurate Hybrid Base is a titanium base designed to interface with a dental implant and
• 05712821000385: The Elos Accurate Hybrid Base is a titanium base designed to interface with a dental implant and
• 05712821000378: The Elos Accurate Hybrid Base is a titanium base designed to interface with a dental implant and
• 05712821000361: The Elos Accurate Hybrid Base is a titanium base designed to interface with a dental implant and
• 05712821000354: The Elos Accurate Hybrid Base is a titanium base designed to interface with a dental implant and
• 05712821000347: The Elos Accurate Hybrid Base is a titanium base designed to interface with a dental implant and