ACTEON

Basic Information

• Brand Name: ACTEON
• Primary DI: 03609820501178
• Version / Model: PIEZOTOME CUBE EMB CANADA
• Catalog Number: F50117
• Company Name: SATELEC
• Labeler DUNS: 381582196
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-12-24
• Public Version: 1
• Public Version Date: 2020-01-01
• Public Version Status: New
• Public Device Record Key: 6de31c86-f16a-4071-b12e-d5c5903beac0

Device Description

With Piezotome® CUBE bone surgery can be performed much faster with maximum power output and patient safety. The CUBE is especially effective with atraumatic extractions. Socket preservation, decreased patient pain and post operative swelling are enhanced with CUBE facilitating immediate implant placement.

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
DZI	Drill, Bone, Powered	Dental	872.4120	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47010	Dental ultrasonic surgical system	An assembly of devices that converts high frequency current into ultrasonic oscillation to mechanically fragment and cut bone upon contact with a vibrating tip during dental surgery, typically in combination with irrigation. It typically includes an energy-producing generator with monitoring functions, a handpiece(s) with tip(s) to convert and apply the energy, connecting cables, and a foot-switch to regulate the energy. It is used for implant-site preparation, dental extraction, distraction, sinus lift, periodontal surgery, cyst removal, extraction of bone block, bone harvesting, osteoplasty and osteotomy.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	03609820501178	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K172137	000