CORiTEC Prosthetic Screw CAS-ATEM188POS

GUDID 05712821012012

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 Dental prosthesis/implant abutment screw Dental prosthesis/implant abutment screw Dental prosthesis/implant abutment screw Dental prosthesis/implant abutment screw Dental prosthesis/implant abutment screw Dental prosthesis/implant abutment screw Dental prosthesis/implant abutment screw Dental prosthesis/implant abutment screw Dental prosthesis/implant abutment screw Dental prosthesis/implant abutment screw Dental prosthesis/implant abutment screw Dental prosthesis/implant abutment screw Dental prosthesis/implant abutment screw Dental prosthesis/implant abutment screw Dental prosthesis/implant abutment screw Dental prosthesis/implant abutment screw

• Primary Device ID: 05712821012012
• NIH Device Record Key: 2a4c5098-f6ff-4a6a-ab93-152c878f8959
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CORiTEC Prosthetic Screw
• Version Model Number: CAS-ATEM188POS
• Catalog Number: CAS-ATEM188POS
• 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	05712821012012 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191890

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

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

[05712821012012]

Moist Heat or Steam Sterilization

[05712821012012]

Moist Heat or Steam Sterilization

[05712821012012]

Moist Heat or Steam Sterilization

[05712821012012]

Moist Heat or Steam Sterilization

[05712821012012]

Moist Heat or Steam Sterilization

[05712821012012]

Moist Heat or Steam Sterilization

[05712821012012]

Moist Heat or Steam Sterilization

[05712821012012]

Moist Heat or Steam Sterilization

[05712821012012]

Moist Heat or Steam Sterilization

[05712821012012]

Moist Heat or Steam Sterilization

[05712821012012]

Moist Heat or Steam Sterilization

[05712821012012]

Moist Heat or Steam Sterilization

[05712821012012]

Moist Heat or Steam Sterilization

[05712821012012]

Moist Heat or Steam Sterilization

[05712821012012]

Moist Heat or Steam Sterilization

[05712821012012]

Moist Heat or Steam Sterilization

[05712821012012]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-11-30
• Device Publish Date: 2023-11-22

On-Brand Devices [CORiTEC Prosthetic Screw]

• 05712821012234: The Prosthetic Screw is provided for a customized abutment to secure the final prosthetic restor
• 05712821012210: The Prosthetic Screw is provided for a customized abutment to secure the final prosthetic restor
• 05712821012203: The Prosthetic Screw is provided for a customized abutment to secure the final prosthetic restor
• 05712821012197: The Prosthetic Screw is provided for a customized abutment to secure the final prosthetic restor
• 05712821012180: The Prosthetic Screw is provided for a customized abutment to secure the final prosthetic restor
• 05712821012173: The Prosthetic Screw is provided for a customized abutment to secure the final prosthetic restor
• 05712821012104: The Prosthetic Screw is provided for a customized abutment to secure the final prosthetic restor
• 05712821012098: The Prosthetic Screw is provided for a customized abutment to secure the final prosthetic restor
• 05712821012081: The Prosthetic Screw is provided for a customized abutment to secure the final prosthetic restor
• 05712821012050: The Prosthetic Screw is provided for a customized abutment to secure the final prosthetic restor
• 05712821012043: The Prosthetic Screw is provided for a customized abutment to secure the final prosthetic restor
• 05712821012029: The Prosthetic Screw is provided for a customized abutment to secure the final prosthetic restor
• 05712821012012: The Prosthetic Screw is provided for a customized abutment to secure the final prosthetic restor
• 05712821012005: The Prosthetic Screw is provided for a customized abutment to secure the final prosthetic restor
• 05712821013316: The Prosthetic Screw is provided for a customized abutment to secure the final prosthetic restor
• 05712821013767: The Prosthetic Screw is provided for a customized abutment to secure the final prosthetic restor