Universal Base

GUDID 05712821003621

The Universal Base is a titanium base designed to interface with a dental implant and to support a patient-specific multi-unit direct restoration cemented to the base. The base and the superstructure form a patient-specific abutment that will support a definitive multi-unit restoration.

Elos Medtech Pinol A/S

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 05712821003621
• NIH Device Record Key: 51404176-9791-4a67-96b9-b82f79855abf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Universal Base
• Version Model Number: 301242
• 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	05712821003621 [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

[05712821003621]

Moist Heat or Steam Sterilization

[05712821003621]

Moist Heat or Steam Sterilization

[05712821003621]

Moist Heat or Steam Sterilization

[05712821003621]

Moist Heat or Steam Sterilization

[05712821003621]

Moist Heat or Steam Sterilization

[05712821003621]

Moist Heat or Steam Sterilization

[05712821003621]

Moist Heat or Steam Sterilization

[05712821003621]

Moist Heat or Steam Sterilization

[05712821003621]

Moist Heat or Steam Sterilization

[05712821003621]

Moist Heat or Steam Sterilization

[05712821003621]

Moist Heat or Steam Sterilization

[05712821003621]

Moist Heat or Steam Sterilization

[05712821003621]

Moist Heat or Steam Sterilization

[05712821003621]

Moist Heat or Steam Sterilization

[05712821003621]

Moist Heat or Steam Sterilization

[05712821003621]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-10-14
• Device Publish Date: 2021-10-06

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