Smartlite Pro Endo Activator

Basic Information

• Brand Name: Smartlite Pro Endo Activator
• Primary DI: D0016444311
• Version / Model: 644431
• Catalog Number: 644431
• Company Name: Dentsply International Inc.
• Labeler DUNS: 606173334
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-11-11
• Public Version: 3
• Public Version Date: 2024-09-11
• Public Version Status: Update
• Public Device Record Key: 71d4b934-2272-4224-81e7-f6d496b67288

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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: Yes
• 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: 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
12535	Medical equipment/instrument drape, single-use	A flexible polymer sheet/bag/sleeve designed to form a protective water-resistant enclosure around a piece of medical equipment/instrument (e.g., C-arm, surgical laser/camera/microscope, examination table/chair) and/or components (e.g., cables, tubes, headrest). It is intended as a hygienic barrier to protect the equipment/instrument from soiling and/or contamination when used inside, or within the vicinity of, a hygienic area; it may have patient contact, however it is not intended to be introduced into a body cavity (noninvasive). It is neither a dedicated handle cover, device cap nor an ultrasound transducer cover. This is a single-use device.	No	Active
43938	Solution agitator	A mains electricity (AC-powered), electromechanical, device typically used to keep substances, e.g., a liquid, liquids, or a combination of particles suspended in these, in a continual motion in order to prevent sedimentation. This device can achieve this by mechanical movement, by ultrasonic means, or other techniques. For devices used during the tapping of blood from blood donors and devices that mix components in the laboratory see the respective GMDN code.	No	Active
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	D0016444311	HIBCC