Elos Accurate® Hexalobular Prosthetic Screw AS-NGMM1610A-1

GUDID 05712821010544

The Prosthetic Screws provided for the Elos Accurate Hybrid Base are used to secure the final prosthetic restoration to the implant. The Prosthetic Screws have a hexalobular driver connection interface.

Elos Medtech Pinol A/S

Dental prosthesis/implant abutment screw

• Primary Device ID: 05712821010544
• NIH Device Record Key: 55ce9597-a934-4173-9f2a-377adb7d197a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Elos Accurate® Hexalobular Prosthetic Screw
• Version Model Number: AS-NGMM1610A-1
• Catalog Number: AS-NGMM1610A-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	05712821010544 [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

[05712821010544]

Moist Heat or Steam Sterilization

[05712821010544]

Moist Heat or Steam Sterilization

[05712821010544]

Moist Heat or Steam Sterilization

[05712821010544]

Moist Heat or Steam Sterilization

[05712821010544]

Moist Heat or Steam Sterilization

[05712821010544]

Moist Heat or Steam Sterilization

[05712821010544]

Moist Heat or Steam Sterilization

[05712821010544]

Moist Heat or Steam Sterilization

[05712821010544]

Moist Heat or Steam Sterilization

[05712821010544]

Moist Heat or Steam Sterilization

[05712821010544]

Moist Heat or Steam Sterilization

[05712821010544]

Moist Heat or Steam Sterilization

[05712821010544]

Moist Heat or Steam Sterilization

[05712821010544]

Moist Heat or Steam Sterilization

[05712821010544]

Moist Heat or Steam Sterilization

[05712821010544]

Moist Heat or Steam Sterilization

[05712821010544]

Moist Heat or Steam Sterilization

[05712821010544]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-10-11
• Device Publish Date: 2023-10-03

On-Brand Devices [Elos Accurate® Hexalobular Prosthetic Screw]

• 05712821002358: The Prosthetic Screws provided for the Elos Accurate Hybrid Base are used to secure the final pr
• 05712821002334: The Prosthetic Screws provided for the Elos Accurate Hybrid Base are used to secure the final pr
• 05712821002327: The Prosthetic Screws provided for the Elos Accurate Hybrid Base are used to secure the final pr
• 05712821002310: The Prosthetic Screws provided for the Elos Accurate Hybrid Base are used to secure the final pr
• 05712821002303: The Prosthetic Screws provided for the Elos Accurate Hybrid Base are used to secure the final pr
• 05712821002297: The Prosthetic Screws provided for the Elos Accurate Hybrid Base are used to secure the final pr
• 05712821002280: The Prosthetic Screws provided for the Elos Accurate Hybrid Base are used to secure the final pr
• 05712821002266: The Prosthetic Screws provided for the Elos Accurate Hybrid Base are used to secure the final pr
• 05712821002228: The Prosthetic Screws provided for the Elos Accurate Hybrid Base are used to secure the final pr
• 05712821002211: The Prosthetic Screws provided for the Elos Accurate Hybrid Base are used to secure the final pr
• 05712821002204: The Prosthetic Screws provided for the Elos Accurate Hybrid Base are used to secure the final pr
• 05712821002198: The Prosthetic Screws provided for the Elos Accurate Hybrid Base are used to secure the final pr
• 05712821002181: The Prosthetic Screws provided for the Elos Accurate Hybrid Base are used to secure the final pr
• 05712821002167: The Prosthetic Screws provided for the Elos Accurate Hybrid Base are used to secure the final pr
• 05712821002150: The Prosthetic Screws provided for the Elos Accurate Hybrid Base are used to secure the final pr
• 05712821002143: The Prosthetic Screws provided for the Elos Accurate Hybrid Base are used to secure the final pr
• 05712821002136: The Prosthetic Screws provided for the Elos Accurate Hybrid Base are used to secure the final pr
• 05712821002129: The Prosthetic Screws provided for the Elos Accurate Hybrid Base are used to secure the final pr
• 05712821002112: The Prosthetic Screws provided for the Elos Accurate Hybrid Base are used to secure the final pr
• 05712821002105: The Prosthetic Screws provided for the Elos Accurate Hybrid Base are used to secure the final pr
• 05712821010544: The Prosthetic Screws provided for the Elos Accurate Hybrid Base are used to secure the final pr
• 05712821010537: The Prosthetic Screws provided for the Elos Accurate Hybrid Base are used to secure the final pr
• 05712821010520: The Prosthetic Screws provided for the Elos Accurate Hybrid Base are used to secure the final pr
• 05712821002341: The Prosthetic Screws provided for the Elos Accurate Hybrid Base are used to secure the final pr
• 05712821002273: The Prosthetic Screws provided for the Elos Accurate Hybrid Base are used to secure the final pr
• 05712821013668: The Prosthetic Screws provided for the Elos Accurate Hybrid Base are used to secure the final pr
• 05712821013651: The Prosthetic Screws provided for the Elos Accurate Hybrid Base are used to secure the final pr
• 05712821013743: The Prosthetic Screws provided for the Elos Accurate Hybrid Base are used to secure the final pr
• 05712821011275: The Prosthetic Screws provided for the Elos Accurate Hybrid Base are used to secure the final pr