Smartlite Pro Endo Activator Activator

Basic Information

• Brand Name: Smartlite Pro Endo Activator Activator
• Primary DI: D0016444361
• Version / Model: 644436
• Catalog Number: 644436
• Company Name: Dentsply International Inc.
• Labeler DUNS: 606173334
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-11-01
• Public Version: 1
• Public Version Date: 2022-11-09
• Public Version Status: New
• Public Device Record Key: 04a9a069-7dc1-4850-93fe-fdd2684b2b7c

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EKQ	PREPARER, ROOT CANAL ENDODONTIC	Dental	872.4565	1

GMDN Terms

Code	Name	Definition	Implantable	Status
63814	Root canal ultrasonic irrigation handpiece tip	A non-sterile, needle-like endpiece designed to be attached to an ultrasonic dental handpiece and intended to deliver irrigation solution to, and provide debridement of, the root canal by means of ultrasonic mechanical vibration, during an endodontic procedure. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	D0016444361	HIBCC

Customer Contacts

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