Heron IOS

Basic Information

• Brand Name: Heron IOS
• Primary DI: 00864206000406
• Version / Model: IOS-FP-71-001
• Company Name: 3D IMAGING AND SIMULATION CORP. AMERICAS
• Labeler DUNS: 117033482
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-09-13
• Public Version: 4
• Public Version Date: 2023-04-04
• Public Version Status: Update
• Public Device Record Key: e7fb3fd6-61fb-4bb5-ba74-b9cebbfba935

Device Description

Heron IOS system is an optical impression system used to record the topographical characteristics of teeth, dental impressions, or stone models for use in the computer aided design and manufacturing of dental restorative prosthetic devices. Heron IOS system consists of a handheld scanner with base, tips (reusable upon autoclave), cables and software.

Device Characteristics

• Single Use: No
• 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: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NOF	System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations	Dental	872.3661	2

GMDN Terms

Code	Name	Definition	Implantable	Status
38597	Dental milling system, CAD/CAM, chairside	An assembly of devices designed for automated computer-aided design (CAD) and computer-aided manufacturing (CAM) of custom-made (prescribed for one patient) dental restorations produced chairside during dental or orthodontic treatment. It typically includes, or is used in conjunction with, three-dimensional (3-D) image acquisition and viewing capabilities that provide values (measurements) for the production phase; software for record collection, treatment planning, simulation and device production; and robotic capabilities for the production of the actual devices to be fitted to the patient.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00864206000406	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -20 – 60 Degrees Celsius
• Type: Handling Environment Temperature
• Temperature Range: 10 – 40 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: 10 – 80 Percent (%) Relative Humidity
• Type: Handling Environment Humidity
• Temperature Range: 10 – 80 Percent (%) Relative Humidity