Elos Accurate Hybrid Base H Engaging

GUDID 05712821007001

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: 05712821007001
• NIH Device Record Key: b84ddf55-de21-4d6d-ac51-f1704219a6cf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Elos Accurate Hybrid Base H Engaging
• Version Model Number: HBE-SBO33H-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	05712821007001 [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

[05712821007001]

Moist Heat or Steam Sterilization

[05712821007001]

Moist Heat or Steam Sterilization

[05712821007001]

Moist Heat or Steam Sterilization

[05712821007001]

Moist Heat or Steam Sterilization

[05712821007001]

Moist Heat or Steam Sterilization

[05712821007001]

Moist Heat or Steam Sterilization

[05712821007001]

Moist Heat or Steam Sterilization

[05712821007001]

Moist Heat or Steam Sterilization

[05712821007001]

Moist Heat or Steam Sterilization

[05712821007001]

Moist Heat or Steam Sterilization

[05712821007001]

Moist Heat or Steam Sterilization

[05712821007001]

Moist Heat or Steam Sterilization

[05712821007001]

Moist Heat or Steam Sterilization

[05712821007001]

Moist Heat or Steam Sterilization

[05712821007001]

Moist Heat or Steam Sterilization

[05712821007001]

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 Engaging]

• 05712821007018: The Elos Accurate Hybrid Base is a titanium base designed to interface with a dental implant and
• 05712821007001: The Elos Accurate Hybrid Base is a titanium base designed to interface with a dental implant and
• 05712821006998: The Elos Accurate Hybrid Base is a titanium base designed to interface with a dental implant and
• 05712821006981: The Elos Accurate Hybrid Base is a titanium base designed to interface with a dental implant and
• 05712821006974: The Elos Accurate Hybrid Base is a titanium base designed to interface with a dental implant and
• 05712821006967: The Elos Accurate Hybrid Base is a titanium base designed to interface with a dental implant and
• 05712821006950: The Elos Accurate Hybrid Base is a titanium base designed to interface with a dental implant and
• 05712821006943: The Elos Accurate Hybrid Base is a titanium base designed to interface with a dental implant and
• 05712821006936: The Elos Accurate Hybrid Base is a titanium base designed to interface with a dental implant and
• 05712821006912: The Elos Accurate Hybrid Base is a titanium base designed to interface with a dental implant and
• 05712821006905: The Elos Accurate Hybrid Base is a titanium base designed to interface with a dental implant and
• 05712821006899: The Elos Accurate Hybrid Base is a titanium base designed to interface with a dental implant and
• 05712821006844: The Elos Accurate Hybrid Base is a titanium base designed to interface with a dental implant and
• 05712821006837: The Elos Accurate Hybrid Base is a titanium base designed to interface with a dental implant and
• 05712821006820: The Elos Accurate Hybrid Base is a titanium base designed to interface with a dental implant and
• 05712821006813: The Elos Accurate Hybrid Base is a titanium base designed to interface with a dental implant and
• 05712821006806: The Elos Accurate Hybrid Base is a titanium base designed to interface with a dental implant and
• 05712821006790: The Elos Accurate Hybrid Base is a titanium base designed to interface with a dental implant and
• 05712821006783: The Elos Accurate Hybrid Base is a titanium base designed to interface with a dental implant and
• 05712821006776: The Elos Accurate Hybrid Base is a titanium base designed to interface with a dental implant and
• 05712821010452: The Elos Accurate Hybrid Base is a titanium base designed to interface with a dental implant and
• 05712821010445: The Elos Accurate Hybrid Base is a titanium base designed to interface with a dental implant and
• 05712821010438: The Elos Accurate Hybrid Base is a titanium base designed to interface with a dental implant and
• 05712821008008: The Elos Accurate Hybrid Base is a titanium base designed to interface with a dental implant and
• 05712821007995: The Elos Accurate Hybrid Base is a titanium base designed to interface with a dental implant and
• 05712821007988: The Elos Accurate Hybrid Base is a titanium base designed to interface with a dental implant and
• 05712821007971: The Elos Accurate Hybrid Base is a titanium base designed to interface with a dental implant and
• 05712821007964: The Elos Accurate Hybrid Base is a titanium base designed to interface with a dental implant and
• 05712821007827: The Elos Accurate Hybrid Base is a titanium base designed to interface with a dental implant and
• 05712821007810: The Elos Accurate Hybrid Base is a titanium base designed to interface with a dental implant and
• 05712821007803: The Elos Accurate Hybrid Base is a titanium base designed to interface with a dental implant and
• 05712821007797: The Elos Accurate Hybrid Base is a titanium base designed to interface with a dental implant and
• 05712821000330: The Elos Accurate Hybrid Base is a titanium base designed to interface with a dental implant and
• 05712821000323: The Elos Accurate Hybrid Base is a titanium base designed to interface with a dental implant and
• 05712821000316: The Elos Accurate Hybrid Base is a titanium base designed to interface with a dental implant and
• 05712821000309: The Elos Accurate Hybrid Base is a titanium base designed to interface with a dental implant and
• 05712821011220: The Elos Accurate Hybrid Base is a titanium base designed to interface with a dental implant and