Elos Accurate® Scan Body Kit N/a

GUDID 05712821016140

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	05712821016140
NIH Device Record Key	1b20f785-1f43-4a64-8a61-7be29dd34fa9
Commercial Distribution Status	In Commercial Distribution
Brand Name	Elos Accurate® Scan Body Kit
Version Model Number	IO 2B 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 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	05712821016140 [Primary]

FDA Product Code

NDP	Accessories, Implant, Dental, Endosseous