Power Dental USA

Basic Information

• Brand Name: Power Dental USA
• Primary DI: D943N7018N00
• Version / Model: N7018N
• Catalog Number: N7018N
• Company Name: Power Dental U.S.A. Inc.
• Labeler DUNS: 081305064
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-07-13
• Public Version: 3
• Public Version Date: 2023-04-12
• Public Version Status: Update
• Public Device Record Key: 506d105f-4cb2-4b3b-a83c-12f414c5b8a9
• Distribution End Date: 2023-03-01

Device Description

SYRINGES ASPIRATED 1.8ml WING, RECOMMEND USE OF PLASTIC NEEDLES (NOT ALUMINIUM)

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• 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
EIC	SYRINGE, PERIODONTIC, ENDODONTIC, IRRIGATING	Dental	872.4565	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35970	Dental irrigation/aspiration syringe	A hand-held manual dental device (a plunger-type syringe) designed to inject and/or aspirate a volume of solution into the working area in the oral cavity. It typically consists of a small syringe (e.g., 3 ml) and is used for washing and aspirating the pulp cavity and root canal to remove debris. It is hand-operated by the user who exerts a steady pressure on, e.g., thumb rings and/or swivel finger bars, which exerts pressure on the syringe plunger forcing the washing/rinsing fluids through an attached needle (e.g., a blunt or very fine needle) directly at the operative site. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	D943N7018N00	HIBCC

Customer Contacts

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