Set iOptima

Basic Information

• Brand Name: Set iOptima
• Primary DI: J00717005440011
• Version / Model: 1700544-001
• Catalog Number: 1700544-001
• Company Name: Bien-Air Dental SA
• Labeler DUNS: 480082080
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-06-17
• Public Version: 1
• Public Version Date: 2021-06-25
• Public Version Status: New
• Public Device Record Key: 74cb308f-9710-4bb2-b82b-02b768d97f6a

Device Description

Sets of iOptima systems and their dental micromotors plus relevant accessories

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: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• 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
EIA	Unit, operative dental	Dental	872.6640	1

GMDN Terms

Code	Name	Definition	Implantable	Status
41264	Surgical power tool system control unit, line-powered	A mains electricity (AC-powered) component of a line-powered surgical/dental power tool system intended to step down the electrical power from the mains to supply the handpiece/motor (not included), and may also be intended to regulate some of the functions of the connected power tools (e.g., speed and torque); it may be intended for single or multiple clinical applications (i.e., dedicated or non-dedicated). This device may have integrated irrigation functionality and may be operated through hand and/or foot controls.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	J00717005440011	HIBCC

Customer Contacts

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