DentaPure Water Purification Bottle Cartridge

GUDID 00732224005522

Water Purification Bottle Cartridge

CROSSTEX INTERNATIONAL, INC.

Dental waterline disinfectant cartridge

• Primary Device ID: 00732224005522
• NIH Device Record Key: a3fb76e1-86fa-4beb-b272-7c418c1da1eb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DentaPure Water Purification Bottle Cartridge
• Version Model Number: *DP40B10
• Company DUNS: 057728685
• Company Name: CROSSTEX INTERNATIONAL, INC.
• Device Count: 10
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(585)359-0167
• Email: regulatoryaffairs@hu-friedy.com
• Phone: +1(585)359-0167
• Email: regulatoryaffairs@hu-friedy.com
• Phone: +1(585)359-0167
• Email: regulatoryaffairs@hu-friedy.com
• Phone: +1(585)359-0167
• Email: regulatoryaffairs@hu-friedy.com
• Phone: +1(585)359-0167
• Email: regulatoryaffairs@hu-friedy.com
• Phone: +1(585)359-0167
• Email: regulatoryaffairs@hu-friedy.com
• Phone: +1(585)359-0167
• Email: regulatoryaffairs@hu-friedy.com
• Phone: +1(585)359-0167
• Email: regulatoryaffairs@hu-friedy.com
• Phone: +1(585)359-0167
• Email: regulatoryaffairs@hu-friedy.com
• Phone: +1(585)359-0167
• Email: regulatoryaffairs@hu-friedy.com
• Phone: +1(585)359-0167
• Email: regulatoryaffairs@hu-friedy.com
• Phone: +1(585)359-0167
• Email: regulatoryaffairs@hu-friedy.com
• Phone: +1(585)359-0167
• Email: regulatoryaffairs@hu-friedy.com
• Phone: +1(585)359-0167
• Email: regulatoryaffairs@hu-friedy.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00732224005522 [Unit of Use]
GS1	50732224005527 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K992868

FDA Product Code

• EIA: Unit, operative dental

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2024-09-16
• Device Publish Date: 2022-11-21

Devices Manufactured by CROSSTEX INTERNATIONAL, INC.

• 00732224005508 - DentaPure 365-Day Independent Water Bottle Cartridge: 2024-09-16 Water Purification Bottle Cartridge
• 00732224005515 - DentaPure Water Purification Municipal Cartridge: 2024-09-16 Water Purification Municipal Cartridge
• 00732224005522 - DentaPure Water Purification Bottle Cartridge: 2024-09-16Water Purification Bottle Cartridge
• 00732224005522 - DentaPure Water Purification Bottle Cartridge: 2024-09-16 Water Purification Bottle Cartridge
• 00732224005690 - Crosstex: 2024-04-29 Soft Adaptors for Hygoformic Saliva Ejectors
• 00732224721484 - Sporview 10 Hour Self Contained BI: 2024-04-18 For use in biologically monitoring steam sterilizers
• 20815878025321 - Burkhart Non-Woven Sponges: 2024-04-17
• 20815878027585 - Burkhart Non-Woven Sponges: 2024-04-17
• 20815878027592 - Burkhart Cotton Rolls: 2024-04-17