MECTRON

Basic Information

• Brand Name: MECTRON
• Primary DI: E322034000090
• Version / Model: EXL2
• Catalog Number: 03400009
• Company Name: MECTRON SPA
• Labeler DUNS: 436664734
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-11-09
• Public Version: 1
• Public Version Date: 2022-11-17
• Public Version Status: New
• Public Device Record Key: 29cacbda-3f7b-4144-8976-697b30cf24c6

Device Description

EXL2 is an extraction surgical insert to be used in conjuntion with Mectron Piezosurgery handpieces

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: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• 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
JDX	Instrument, Surgical, Sonic And Accessory/Attachment	Orthopedic	888.4580	2
DZI	Drill, Bone, Powered	Dental	872.4120	2
ELC	Scaler, Ultrasonic	Dental	872.4850	2
ERL	Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece	Ear, Nose, Throat	874.4250	2
HBE	Drills, Burrs, Trephines & Accessories (Simple, Powered)	Neurology	882.4310	2
HWE	Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	General, Plastic Surgery	878.4820	1

GMDN Terms

Code	Name	Definition	Implantable	Status
47015	Dental ultrasonic surgical system handpiece tip	A removable endpiece intended to be attached to a dental ultrasonic surgical system handpiece, and makes contact with a patient while oscillating (vibrating) at high frequency in order to mechanically fragment and cut bone during dental surgery. The device is available in a variety of forms (e.g., flat serrated blade, ball head, nail head, or probe-like) and sizes, and is typically made of metal; it is not intended to be held directly (i.e., does not include a holder). 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. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	E322034000090	HIBCC

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K122322	000
K132848	000
K151248	000