Scan Body

GUDID 05712821007377

The Scan Body is intended to be used together with a dental scanner to locate the exact position of an implant/analog or abutment in relation to prosthetic restorations. The scan body is intended to be mounted directly on the implant/analog or abutment using the Scan Body Driver/Neo Screwdriver. The Scan Body is intended to be used directly in a patient’s mouth when using an Intra oral scanner, or on a model of the patients’ teeth setup when using a desktop scanner.

Elos Medtech Pinol A/S

Dental implant suprastructure, temporary, preformed, reusable

• Primary Device ID: 05712821007377
• NIH Device Record Key: cb4cd6e5-7a40-4871-8310-07914daf7264
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Scan Body
• Version Model Number: 90182
• Company DUNS: 306155953
• Company Name: Elos Medtech Pinol A/S
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• 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	05712821007377 [Primary]
GS1	05712821009333 [Direct Marking]

FDA Product Code

• NDP: Accessories, Implant, Dental, Endosseous

Sterilization

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

[05712821007377]

Moist Heat or Steam Sterilization

[05712821007377]

Moist Heat or Steam Sterilization

[05712821007377]

Moist Heat or Steam Sterilization

[05712821007377]

Moist Heat or Steam Sterilization

[05712821007377]

Moist Heat or Steam Sterilization

[05712821007377]

Moist Heat or Steam Sterilization

[05712821007377]

Moist Heat or Steam Sterilization

[05712821007377]

Moist Heat or Steam Sterilization

[05712821007377]

Moist Heat or Steam Sterilization

[05712821007377]

Moist Heat or Steam Sterilization

[05712821007377]

Moist Heat or Steam Sterilization

[05712821007377]

Moist Heat or Steam Sterilization

[05712821007377]

Moist Heat or Steam Sterilization

[05712821007377]

Moist Heat or Steam Sterilization

[05712821007377]

Moist Heat or Steam Sterilization

[05712821007377]

Moist Heat or Steam Sterilization

[05712821007377]

Moist Heat or Steam Sterilization

[05712821007377]

Moist Heat or Steam Sterilization

[05712821007377]

Moist Heat or Steam Sterilization

[05712821007377]

Moist Heat or Steam Sterilization

[05712821007377]

Moist Heat or Steam Sterilization

[05712821007377]

Moist Heat or Steam Sterilization

[05712821007377]

Moist Heat or Steam Sterilization

[05712821007377]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-12-21
• Device Publish Date: 2020-12-11

On-Brand Devices [Scan Body]

• 05712821007384: The Scan Body is intended to be used together with a dental scanner to locate the exact position
• 05712821007377: The Scan Body is intended to be used together with a dental scanner to locate the exact position
• 05712821007360: The Scan Body is intended to be used together with a dental scanner to locate the exact position