Elos Accurate Hybrid Base H Engaging HBE-BCE34-1

GUDID 05712821000309

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 Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed

• Primary Device ID: 05712821000309
• NIH Device Record Key: 2dc74b20-5fc1-4f68-aeb6-386c8e85dfb8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Elos Accurate Hybrid Base H Engaging
• Version Model Number: HBE-BCE34-1
• Catalog Number: HBE-BCE34-1
• 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	05712821000309 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K230317

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

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

[05712821000309]

Moist Heat or Steam Sterilization

[05712821000309]

Moist Heat or Steam Sterilization

[05712821000309]

Moist Heat or Steam Sterilization

[05712821000309]

Moist Heat or Steam Sterilization

[05712821000309]

Moist Heat or Steam Sterilization

[05712821000309]

Moist Heat or Steam Sterilization

[05712821000309]

Moist Heat or Steam Sterilization

[05712821000309]

Moist Heat or Steam Sterilization

[05712821000309]

Moist Heat or Steam Sterilization

[05712821000309]

Moist Heat or Steam Sterilization

[05712821000309]

Moist Heat or Steam Sterilization

[05712821000309]

Moist Heat or Steam Sterilization

[05712821000309]

Moist Heat or Steam Sterilization

[05712821000309]

Moist Heat or Steam Sterilization

[05712821000309]

Moist Heat or Steam Sterilization

[05712821000309]

Moist Heat or Steam Sterilization

[05712821000309]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-04-25
• Device Publish Date: 2024-04-17

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