ACTEON

Basic Information

• Brand Name: ACTEON
• Primary DI: 03609820873213
• Version / Model: KIT NEWTRON PARO
• Catalog Number: F87321
• Company Name: SATELEC
• Labeler DUNS: 381582196
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 90de375c-390d-474f-a5a3-4adcaa14cb8c

Device Description

The tips (H3, H4L/R) used with a push stroke without scraping are designed for : - sub-gingival scaling, - non-surgical treatment of deep and narrow pockets (>4-6mm), - open treatments (flap surgery). Diamond-coated tips (H1, H2L/R), used in the second step, are designed to remove calculus from very narrow inter-root spaces and furcations. They are used with very low pressure and are also recommended for the debridement of periodontal abscesses and for odontoplasty during non-surgical treatment.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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: 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: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
ELC	Scaler, Ultrasonic	Dental	872.4850	2

GMDN Terms

Code	Name	Definition	Implantable	Status
44908	Ultrasonic dental scaling/debridement system handpiece tip, periodontal	An insert intended to be attached to an ultrasonic dental scaling/debridement system handpiece, to transmit ultrasonic energy (e.g., 25 kHz/30 kHz) from a generator to the oral cavity for the removal of accretions from tooth surfaces during dental cleaning or periodontal therapy; it is not intended for endodontic use. This device vibrates at a high frequency to provide the scaling effect. Water or a rinsing solution (e.g., chlorhexidine) is intended to be fed through the handpiece/tip assembly to assist in the process. This device is available in a variety of designs and tip shapes. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	03609820873213	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K132322	000