DentaKLEEN®

Basic Information

• Brand Name: DentaKLEEN®
• Primary DI: 00854542008150
• Version / Model: (01)00854542008150(10)3030951384
• Catalog Number: ITEM #: MAK-1900
• Company Name: Anodia Systems
• Labeler DUNS: 030080456
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-07-18
• Public Version: 1
• Public Version Date: 2023-07-26
• Public Version Status: New
• Public Device Record Key: c3f63079-b000-42bb-8eed-1470dc2878ab

Device Description

DentaKLEEN is used for dental units on city water in which the dental lines are to be cleaned (Manufacturer # MAK-1900). Designed with toggle switches allowing the dental personnel to have complete control of the cleaning. One toggle switch controls the incoming water to the dental unit in reference to being on or off. The other toggle switch allows the dental personnel to air purge the waterlines and then inject a liquid cleaner into the waterlines.

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: 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: 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
34991	Dental delivery system	A stationary, mains electricity (AC-powered) device assembly designed to provide dental staff with the necessary utilities/amenities to deliver dental treatment to a patient. The utilities/amenities are typically compressed air, water, suction, electricity, table top or bracket table surfaces, cuspidor, gas, and sometimes the dental light. This is a fixed-position system (i.e., not mobile) which incorporates an instrument unit for dental instrument provision. The patient examination/treatment chair is typically integrated as part of this system.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00854542008150	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K023815	000