AccessGUDID - DEVICE: DentaKLEEN® (00854542008150)

GUDID

Device Identifier (DI) Information

Brand Name: DentaKLEEN®
Version or Model: (01)00854542008150(10)3030951384
Commercial Distribution Status: In Commercial Distribution
Catalog Number: ITEM #: MAK-1900
Company Name: Anodia Systems

Primary DI Number: 00854542008150
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 030080456 *Terms of Use

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

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EIA	Unit, Operative Dental

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K023815	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: c3f63079-b000-42bb-8eed-1470dc2878ab
Public Version Date: July 26, 2023
Public Version Number: 1
DI Record Publish Date: July 18, 2023