DentaPure Dental Unit Water Purification Cartridge

Basic Information

• Brand Name: DentaPure Dental Unit Water Purification Cartridge
• Primary DI: 10732224005505
• Version / Model: DP365B
• Catalog Number: DP365B
• Company Name: CROSSTEX INTERNATIONAL, INC.
• Labeler DUNS: 057728685
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-09-15
• Public Version: 1
• Public Version Date: 2023-09-25
• Public Version Status: New
• Public Device Record Key: 05059116-3929-46bf-82b9-14622453001e

Device Description

365 day independent water filter

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
61137	Legionella water purification filter	A device intended to remove Legionella bacteria from flowing water to reduce the risk of Legionella contamination during body washing for hygiene; it is not intended for medical washing/irrigation and is not intended for general microbial filtration. It typically consists of a plastic housing with a connector attached to the water source [e.g., a tap (faucet)] and a filtering membrane [e.g., made of polyethersulfone (PES)]; it may include a distal shower rose/directing nozzle. 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
Primary	10732224005505	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K992893	000