Pro-Sonic®

Basic Information

• Brand Name: Pro-Sonic®
• Primary DI: D6870021352FG1
• Version / Model: 0021352FG
• Catalog Number: 0021352FG
• Company Name: DENTSPLY INTERNATIONAL INC.
• Labeler DUNS: 083235549
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 4
• Record Status: Published
• Publish Date: 2016-09-21
• Public Version: 5
• Public Version Date: 2022-12-27
• Public Version Status: Update
• Public Device Record Key: b4f38fd0-e48b-4ec1-9b4e-043b756ed56b
• Distribution End Date: 2022-12-27

Device Description

Pro-Sonic® Tartar & Stain Remover

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: Yes
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EFT	CLEANSER, DENTURE, OVER THE COUNTER	Dental	872.3520	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35871	Denture cleanser	An agent intended to be used to remove soft debris from removable prosthetic dental appliances (e.g., dentures or bridges), normally by the immersion of the prosthesis/appliance in the agent overnight and/or mechanical cleaning with a toothbrush. It is intended for home-use and/or for hospitalized or institutionalized patients. After application, this device cannot be reused.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	D6870021352FG1	HIBCC
Unit of Use	D6870021352FG0	HIBCC

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			1 gallon (3.8L)
Total Volume	3.8	Liter