Patterson®

Basic Information

• Brand Name: Patterson®
• Primary DI: D6620712170740
• Version / Model: 71217074
• Catalog Number: 71217074
• Company Name: PATTERSON DENTAL SUPPLY, INC.
• Labeler DUNS: 171843584
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-05-08
• Public Version: 2
• Public Version Date: 2024-09-02
• Public Version Status: Update
• Public Device Record Key: f6978956-2b2e-4c24-b4f2-682fa82f61a7

Device Description

SCALER, ULTRASONIC

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: No
• 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: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
ELC	Scaler, ultrasonic	Dental	872.4850	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47014	Dental ultrasonic surgical system handpiece	A hand-held component of a dental ultrasonic surgical system that typically converts high frequency electrical current from a generator into an ultrasonic oscillation, for a tip placed at its end to mechanically fragment and cut bone upon contact during dental surgery. The operator regulates the energy with an electric power switch incorporated into a foot-pedal that is attached to the generator. The handpiece typically includes cables and tubing, and may serve as a conduit for irrigation to the site of intervention. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	D6620712170740	HIBCC

Premarket Submissions

Submission Number	Supplement Number
K012060	000