ScanBody EV (L) 68020520

GUDID 05712821014641

The Scan Body is used as an accessory for dental scanners in order to locate the exact position of the implants placed in the patient’s jawbone. The Scan Body is intended to be attached to the implant/abutment directly in the patients’ mouth when using an intra-oral scanner. It is manufactured from biocompatible titanium alloy (TiAl6V4 ELI). The Scan Body Driver that is provided separately, is used to fasten the Scan Body to the Implant.

Elos Medtech Pinol A/S

Dental implant suprastructure, temporary, preformed, reusable

• Primary Device ID: 05712821014641
• NIH Device Record Key: 02403aa7-ccdc-4e57-bf70-d6bfe77bb527
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ScanBody EV (L)
• Version Model Number: 68020520
• Catalog Number: 68020520
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	05712821014641 [Primary]

FDA Product Code

• NDP: Accessories, Implant, Dental, Endosseous

Sterilization

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

[05712821014641]

Moist Heat or Steam Sterilization

[05712821014641]

Moist Heat or Steam Sterilization

[05712821014641]

Moist Heat or Steam Sterilization

[05712821014641]

Moist Heat or Steam Sterilization

[05712821014641]

Moist Heat or Steam Sterilization

[05712821014641]

Moist Heat or Steam Sterilization

[05712821014641]

Moist Heat or Steam Sterilization

[05712821014641]

Moist Heat or Steam Sterilization

[05712821014641]

Moist Heat or Steam Sterilization

[05712821014641]

Moist Heat or Steam Sterilization

[05712821014641]

Moist Heat or Steam Sterilization

[05712821014641]

Moist Heat or Steam Sterilization

[05712821014641]

Moist Heat or Steam Sterilization

[05712821014641]

Moist Heat or Steam Sterilization

[05712821014641]

Moist Heat or Steam Sterilization

[05712821014641]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-12-03
• Device Publish Date: 2024-11-25

Devices Manufactured by Elos Medtech Pinol A/S

• 05712821012876 - Elos Accurate® Scan Body 22: 2025-01-30 The Scan Body is used as an accessory for dental scanners in order to locate the exact position of the implants placed in the pa
• 05712821012920 - Elos Accurate® Scan Body 22: 2025-01-30 The Scan Body is used as an accessory for dental scanners in order to locate the exact position of the implants placed in the pa
• 05712821012937 - Elos Accurate® Scan Body 22: 2025-01-30 The Scan Body is used as an accessory for dental scanners in order to locate the exact position of the implants placed in the pa
• 05712821012944 - Elos Accurate® Scan Body 22: 2025-01-30 The Scan Body is used as an accessory for dental scanners in order to locate the exact position of the implants placed in the pa
• 05712821012951 - Elos Accurate® Scan Body 22: 2025-01-30 The Scan Body is used as an accessory for dental scanners in order to locate the exact position of the implants placed in the pa
• 05712821012968 - Elos Accurate® Scan Body 22: 2025-01-30 The Scan Body is used as an accessory for dental scanners in order to locate the exact position of the implants placed in the pa
• 05712821012975 - Elos Accurate® Scan Body 22: 2025-01-30 The Scan Body is used as an accessory for dental scanners in order to locate the exact position of the implants placed in the pa
• 05712821012982 - Elos Accurate® Scan Body 22: 2025-01-30 The Scan Body is used as an accessory for dental scanners in order to locate the exact position of the implants placed in the pa