DentaPure 365-Day Independent Water Bottle Cartridge

Basic Information

• Brand Name: DentaPure 365-Day Independent Water Bottle Cartridge
• Primary DI: D711DP365B100
• Version / Model: DP365B10
• Catalog Number: DP365B10
• Company Name: MEDIVATORS INC.
• Labeler DUNS: 068199363
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2023-09-22
• Public Version: 1
• Public Version Date: 2023-10-02
• Public Version Status: New
• Public Device Record Key: 78ebabe3-04e4-4827-bc40-b7e8414ef314

Device Description

Water Bottle Cartridge

Device Characteristics

• Single Use: Yes
• 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: No
• 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
EIA	Unit, operative dental	Dental	872.6640	1

GMDN Terms

Code	Name	Definition	Implantable	Status
62906	Dental waterline disinfectant cartridge	A device in the form of a cartridge containing a disinfectant (e.g., iodine resin) intended to be integrated within a dental waterline (i.e., water fed to certain dental instruments) to maintain disinfection of the water prior to patient contact through introduction of the disinfectant. This is a disposable device not intended to be reprocessed, which has a multiple-patient use application (reusable).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	D711DP365B0	HIBCC
Primary	D711DP365B100	HIBCC

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K992893	000