FDA.reportPublic FDA data

DentaKLEEN®

Primary DI
00854542008150
Brand
DentaKLEEN®
Company
Anodia Systems
Model
(01)00854542008150(10)3030951384
Catalog number
ITEM #: MAK-1900
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.
Published
2023-07-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
EIAUnit, Operative Dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EIAUnit, Operative DentalDental1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K023815000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K023815000C-1805MAnodia Systems2003-06-19EIA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00854542008150PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00854542008150008545420081508545420081500854542008150

GMDN Terms#

Term, Definition table
TermDefinition
Dental delivery systemA 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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
866-246-2548info@AnodiaSystems.com

Regulatory Flags#

DUNS number
030080456
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00854542008037PRO-KLEEN854542008037MAK-19102023-08-19
00854542008211Zoral00854542008372item # MAK-13102023-08-19
00854542008167WaterlineX®(01)854542008167(10)204008ITEM #: MAK-18062023-08-06
00854542008198Zoral Scaler Solution®MAK-Z12023-08-06
00854542008204Zoral Scaler Solution® MAK-Z42023-08-06
00854542008044STERI-SOL® SYSTEM(01)00854542008044(21)101920213030ITEM #: MAK-STERI2023-07-18
00854542008334Steri-Sol® Dental Handpiece Cutting Solution00854542008334ITEM # MAK-STERI-SOL2023-07-18
00854542008341VELOCITY WATER®(01)00854542008341ITEM #: MAK-18052023-07-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800156000013ELEC MasterMGNEWTON Co. LTD.,EIA2026-04-30
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J00715021230011BOARD DMX3 M BtoBBIEN-AIR PORTUGAL, UNIPESSOAL, LDAEIA2026-02-24
J00716012590011Console Optima INTBien-Air Dental SAEIA2025-11-10
08800053083249Luvis Chair (LC700C)DENTIS CO. ,LTDEIA2024-09-19
50732224005671DentaPure Water Purification Bottle CartridgeCROSSTEX INTERNATIONAL, INC.EIA2024-04-08
50732224005688DentaPure Water Purification Municipal CartridgeCROSSTEX INTERNATIONAL, INC.EIA2024-04-08
J00716011960051IDUP boardBien-Air Dental SAEIA2023-09-11
J021303530001MC-2.0 I (Motorcontroller Implantology)W & H Dentalwerk Bürmoos GmbHEIA2023-07-19
J021303580001Perestaltic Pump W & H Dentalwerk Bürmoos GmbHEIA2023-07-19
J021303630001EXP-PD-ST-00 (Pump Controller)W & H Dentalwerk Bürmoos GmbHEIA2023-07-19
J021302780001MC-1.0 and AD-1.0 Analog MotorcontrollerW & H Dentalwerk Bürmoos GmbHEIA2023-07-11
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