Elos Prosthetic Screw

GUDID 05712821002082

The Prosthetic Screw is provided for a customized abutment to secure the final prosthetic restoration to the implant in the patient’s mouth. The Prosthetic Screws is intended to be used with customized abutment from a Elos Medtech approved milling center. The Prosthetic Screw is provided none-sterile and is intended to be sterilized prior to installation in the patient’s mouth. The Prosthetic Screws are designed for single one-time use in the patient’s mouth.

Elos Medtech Pinol A/S

Dental prosthesis/implant abutment screw

• Primary Device ID: 05712821002082
• NIH Device Record Key: 3040d78d-d13a-47b1-9ebf-8f1426e9762e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Elos Prosthetic Screw
• Version Model Number: AS-ATEM148POS
• 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	05712821002082 [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

[05712821002082]

Moist Heat or Steam Sterilization

[05712821002082]

Moist Heat or Steam Sterilization

[05712821002082]

Moist Heat or Steam Sterilization

[05712821002082]

Moist Heat or Steam Sterilization

[05712821002082]

Moist Heat or Steam Sterilization

[05712821002082]

Moist Heat or Steam Sterilization

[05712821002082]

Moist Heat or Steam Sterilization

[05712821002082]

Moist Heat or Steam Sterilization

[05712821002082]

Moist Heat or Steam Sterilization

[05712821002082]

Moist Heat or Steam Sterilization

[05712821002082]

Moist Heat or Steam Sterilization

[05712821002082]

Moist Heat or Steam Sterilization

[05712821002082]

Moist Heat or Steam Sterilization

[05712821002082]

Moist Heat or Steam Sterilization

[05712821002082]

Moist Heat or Steam Sterilization

[05712821002082]

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 Prosthetic Screw]

• 05712821001993: The Prosthetic Screw is provided for a customized abutment to secure the final prosthetic restor
• 05712821006592: The Prosthetic Screw is provided for a customized abutment to secure the final prosthetic restor
• 05712821006585: The Prosthetic Screw is provided for a customized abutment to secure the final prosthetic restor
• 05712821002099: The Prosthetic Screw is provided for a customized abutment to secure the final prosthetic restor
• 05712821001986: The Prosthetic Screw is provided for a customized abutment to secure the final prosthetic restor
• 05712821001979: The Prosthetic Screw is provided for a customized abutment to secure the final prosthetic restor
• 05712821001962: The Prosthetic Screw is provided for a customized abutment to secure the final prosthetic restor
• 05712821001955: The Prosthetic Screw is provided for a customized abutment to secure the final prosthetic restor
• 05712821001948: The Prosthetic Screw is provided for a customized abutment to secure the final prosthetic restor
• 05712821001917: The Prosthetic Screw is provided for a customized abutment to secure the final prosthetic restor
• 05712821001900: The Prosthetic Screw is provided for a customized abutment to secure the final prosthetic restor
• 05712821001894: The Prosthetic Screw is provided for a customized abutment to secure the final prosthetic restor
• 05712821001863: The Prosthetic Screw is provided for a customized abutment to secure the final prosthetic restor
• 05712821001856: The Prosthetic Screw is provided for a customized abutment to secure the final prosthetic restor
• 05712821002259: The Prosthetic Screw is provided for a customized abutment to secure the final prosthetic restor
• 05712821002242: The Prosthetic Screw is provided for a customized abutment to secure the final prosthetic restor
• 05712821002235: The Prosthetic Screw is provided for a customized abutment to secure the final prosthetic restor
• 05712821002082: The Prosthetic Screw is provided for a customized abutment to secure the final prosthetic restor
• 05712821001849: The Prosthetic Screw is provided for a customized abutment to secure the final prosthetic restor
• 05712821001931: The Prosthetic Screws provided for the Elos Accurate Hybrid Base are used to secure the final pr
• 05712821001924: The Prosthetic Screws provided for the Elos Accurate Hybrid Base are used to secure the final pr
• 05712821010513: The Prosthetic Screw is provided for a customized abutment to secure the final prosthetic restor
• 05712821010506: The Prosthetic Screw is provided for a customized abutment to secure the final prosthetic restor
• 05712821010490: The Prosthetic Screw is provided for a customized abutment to secure the final prosthetic restor
• 05712821002013: The Prosthetic Screw is provided for a customized abutment to secure the final prosthetic restor
• 05712821002006: The Prosthetic Screw is provided for a customized abutment to secure the final prosthetic restor
• 05712821013750: The Prosthetic Screw is provided for a customized abutment to secure the final prosthetic restor
• 05712821011282: The Prosthetic Screw is provided for a customized abutment to secure the final prosthetic restor