MECTRON

Basic Information

• Brand Name: MECTRON
• Primary DI: E322031201341010
• Version / Model: PS TOUCH COMPLETE HANDPIECE
• Catalog Number: 03120134-101
• Company Name: MECTRON SPA
• Labeler DUNS: 436664734
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-02
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 6b1ee072-7cee-4de8-a036-d6ffa20c43f0

Device Description

Piezoelectric ultrasonic handpiece with cord to be used in conjunction with Mectron Piezosurgery devices and tip inserts for the following applications: 1) Bone cutting, osteotomy, osteoplasty and drilling in a variety of oral surgical procedures.including implantalogy, periodontal surgery, surgical orthodontic, and surgical endodonticprocedures; 2) Scaling applications, including: - Scaling: All general procedures for removal of supragingival and interdental calculus & plaquedeposits - Periodontology: Periodontal therapy and debridenient for all types of periodontal diseases,including periodontal pocket irrigation and cleaning: - Endodontics: All treatments for root canal reaming, irrigation, revision, filling, gutta-perchacondensation and retrograde preparation; - Restorative and Prosthetics: Cavity preparation, removal of prostheses, amalgam condensation, finishing of crown preparations and inlay/onlay condensation.

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: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
ELC	Scaler, Ultrasonic	Dental	872.4850	2
DZI	Drill, Bone, Powered	Dental	872.4120	2

GMDN Terms

Code	Name	Definition	Implantable	Status
44907	Ultrasonic dental scaling/debridement system handpiece	A hand-held component of an ultrasonic dental debridement system intended to convert high frequency electrical current from a generator into an ultrasonic oscillation, for a tip placed at its end to mechanically fragment and dislodge gross debris/accretions during an endodontic and/or periodontal procedure. It may also serve as a conduit for fluid intended to prevent overheating of the tip and surrounding tissue. This device is typically in the form of a pen/pencil with attached cables. This is a reusable device.	No	Active
47014	Dental ultrasonic surgical system handpiece	A hand-held component of a dental ultrasonic surgical system that typically converts high frequency electrical current from a generator into an ultrasonic oscillation, for a tip placed at its end to mechanically fragment and cut bone upon contact during dental surgery. The operator regulates the energy with an electric power switch incorporated into a foot-pedal that is attached to the generator. The handpiece typically includes cables and tubing, and may serve as a conduit for irrigation to the site of intervention. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	E322031201341010	HIBCC

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K151248	000