Power Dental USA

Basic Information

• Brand Name: Power Dental USA
• Primary DI: D943P29090
• Version / Model: P2909
• Catalog Number: P2909
• 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: 2022-03-23
• Public Version: 3
• Public Version Date: 2023-06-23
• Public Version Status: Update
• Public Device Record Key: be953b79-d5b1-4094-9086-89a0be965f03

Device Description

PLASTIC FILLING W3 PFIW3

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: 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
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
38530	Dental spatula, reusable	A hand-held manual dental device used to manipulate filling materials in the plastic state. It is typically made of stainless steel with a small, flat, blunt blade (no sharp edges) at one end, or it may be double-ended. This is a reusable device.	No	Active
35697	Dental material application tool, single-use	A hand-held manual dental instrument intended to be used for the application of a dental restorative material (e.g., amalgam, resin) to a patient’s tooth/teeth; the restorative material is not included. It includes a handle with an application tip/brush which holds the material on its surface/bristles; it is not a syringe- or pistol-like device. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	D943P29090	HIBCC

Customer Contacts

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