Elos Accurate® Scan Body Kit N/a

GUDID 05712821005458

The Scan Body is manufactured from biocompatible titanium alloy (TiAl6V4 ELI) and polyetheretherketone (PEEK). The corresponding Scan Body Driver used to tighten the integrated screw is manufactured from biocompatible stainless steel. The product is available for a variety of implant platforms. For specific product descriptions, please refer to individual product labels.

Elos Medtech Pinol A/S

Dental implant suprastructure, temporary, preformed, reusable

• Primary Device ID: 05712821005458
• NIH Device Record Key: 8ec08cbc-27e6-4372-a247-4f9e06dbda3c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Elos Accurate® Scan Body Kit
• Version Model Number: IO 2B SA Kit
• Catalog Number: N/a
• 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 Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	05712821005458 [Primary]

FDA Product Code

• NDP: Accessories, Implant, Dental, Endosseous

Sterilization

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

[05712821005458]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-03-19
• Device Publish Date: 2020-03-11

On-Brand Devices [Elos Accurate® Scan Body Kit]

• 05712821005915: The Scan Body is manufactured from biocompatible titanium alloy (TiAl6V4 ELI) and polyetherether
• 05712821005885: The Scan Body is manufactured from biocompatible titanium alloy (TiAl6V4 ELI) and polyetherether
• 05712821005502: The Scan Body is manufactured from biocompatible titanium alloy (TiAl6V4 ELI) and polyetherether
• 05712821005458: The Scan Body is manufactured from biocompatible titanium alloy (TiAl6V4 ELI) and polyetherether
• 05712821005403: The Scan Body is manufactured from biocompatible titanium alloy (TiAl6V4 ELI) and polyetherether
• 05712821016140: The Scan Body is manufactured from biocompatible titanium alloy (TiAl6V4 ELI) and polyetherether