Power Dental USA

Basic Information

• Brand Name: Power Dental USA
• Primary DI: D9434001S0
• Version / Model: 4001S
• Catalog Number: 4001S
• Company Name: Power Dental U.S.A. Inc.
• Labeler DUNS: 081305064
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-02-28
• Public Version: 1
• Public Version Date: 2023-03-08
• Public Version Status: New
• Public Device Record Key: e4541e24-9453-4d45-9c98-dcb9a625a6e1

Device Description

X POWER ROOT TIP PICKS SPECIALLY OPTIMIZED TO GO DEEP, LEFT / RIGHT. SET OF 2 4001 X POWER ROOT TIP PICKS (LEFT), SPECIALLY OPTIMIZED TO GO DEEP . DAVIS TEASERS 2, AVOID EXCESSIVE PRESSURE, NOT TO BE USED AS AN ELEVATOR 4002 X POWER ROOT TIP PICKS (RIGHT), SPECIALLY OPTIMIZED TO GO DEEP. DAVIS TEASERS 3, AVOID EXCESSIVE PRESSURE, NOT TO BE USED AS AN ELEVATOR

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: No
• 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
EMJ	Elevator, Surgical, Dental	Dental	872.4565	1

GMDN Terms

Code	Name	Definition	Implantable	Status
16480	Dental elevator, tooth/root	A hand-held, manual, dental surgical instrument intended to be used as a lever during the extraction of a tooth or retained roots. It is typically a one-piece instrument with a strong but slender blade at the distal working end, or it may be double-ended with a central handle. It is available in a variety of sizes and blade designs and is pushed in between the gums and the tooth exterior to loosen the tissue surrounding the tooth. Sometimes this can be enough to loosen and extract the tooth without the use of other instruments. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	D9434001S0	HIBCC

Customer Contacts

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