Power Dental USA

Basic Information

• Brand Name: Power Dental USA
• Primary DI: D943N3220
• Version / Model: N3220
• Catalog Number: N3220
• 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: 2021-06-20
• Public Version: 3
• Public Version Date: 2022-12-19
• Public Version Status: Update
• Public Device Record Key: 1a810c44-05d4-4cc8-befa-e0513b156b3e
• Distribution End Date: 2022-12-16

Device Description

CASI- 3C, 2+6MM, SHARPER EDGE

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
EIY	INSTRUMENT, FILLING, PLASTIC, DENTAL	Dental	872.4565	1

GMDN Terms

Code	Name	Definition	Implantable	Status
31863	Margin finishing dental file/rasp, reusable	A hand-held manual dental instrument that has various forms of fine ridged cutting surfaces at its working end(s) designed to smooth and shape a tooth, an approximate bone (e.g., alveolar) and/or a dental restoration (e.g., filling). It is typically a one-piece instrument available in a variety of sizes and working end designs, including straight and curved ends, and often double-ended with a central handle; it is made of metal [e.g., stainless steel, titanium (Ti)]. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	D943N3220	HIBCC

Customer Contacts

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