Elos Accurate® Model Analog

Basic Information

• Brand Name: Elos Accurate® Model Analog
• Primary DI: 05712821004178
• Version / Model: MA-DXI30-1
• Catalog Number: N/A
• Company Name: Elos Medtech Pinol A/S
• Labeler DUNS: 306155953
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-03-11
• Public Version: 1
• Public Version Date: 2020-03-19
• Public Version Status: New
• Public Device Record Key: 9543ace2-8d57-4b26-82e1-afb0a16bf132

Device Description

The product consists of the Elos Accurate® Model Analog (Analog) manufactured in biocompatible titanium alloy grade 5 ELI (TiAl6V4 ELI).

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NDP	Accessories, Implant, Dental, Endosseous	Dental	872.3980	1

GMDN Terms

Code	Name	Definition	Implantable	Status
61642	Dental implant analog	A device intended to be used as a copy of a dental implant, for a dental laboratory working model, to duplicate the location and restorative platform orientation of the final dental implant; it is not intended for intraoral use. It is a rod-like device made of metal [e.g., titanium (Ti)]. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05712821004178	GS1

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 10 – 40 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: 0 – 80 Percent (%) Relative Humidity