GentleCLEAN™

Basic Information

• Brand Name: GentleCLEAN™
• Primary DI: 10810000522733
• Version / Model: DSG30GCT
• Catalog Number: DSG30GCT
• Company Name: PARKELL, INC.
• Labeler DUNS: 009900424
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 50
• Record Status: Published
• Publish Date: 2018-11-02
• Public Version: 4
• Public Version Date: 2023-12-20
• Public Version Status: Update
• Public Device Record Key: 38944537-1031-43e0-ab9e-72ce17e7db10

Device Description

Tips for GentleCLEAN™ Insert (Pkg. of 50 pcs.)

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• 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: Yes
• 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
ELC	Scaler, Ultrasonic	Dental	872.4850	2

GMDN Terms

Code	Name	Definition	Implantable	Status
44908	Ultrasonic dental scaling/debridement system handpiece tip, periodontal	An insert intended to be attached to an ultrasonic dental scaling/debridement system handpiece, to transmit ultrasonic energy (e.g., 25 kHz/30 kHz) from a generator to the oral cavity for the removal of accretions from tooth surfaces during dental cleaning or periodontal therapy; it is not intended for endodontic use. This device vibrates at a high frequency to provide the scaling effect. Water or a rinsing solution (e.g., chlorhexidine) is intended to be fed through the handpiece/tip assembly to assist in the process. This device is available in a variety of designs and tip shapes. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10810000522733	GS1
Unit of Use	00810000522736	GS1

Customer Contacts

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