FDA.reportPublic FDA data

PRO-KLEEN

Primary DI
00854542008037
Brand
PRO-KLEEN
Company
Anodia Systems
Model
854542008037
Catalog number
MAK-1910
Device description
PRO-KLEEN is a pressurized dental unit waterline cleaning system designed to clean dental units on city water that do not have a dental unit water bottle system (Manufacturer # MAK-1910). Toggle switch controls Air Purge or liquid dental waterline cleaning solution injection.
Published
2023-08-19
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
00854542008037PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00854542008037008545420080378545420080370854542008037

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
8662462548info@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
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
00854542008150DentaKLEEN®(01)00854542008150(10)3030951384ITEM #: MAK-19002023-07-18
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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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
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J021302780001MC-1.0 and AD-1.0 Analog MotorcontrollerW & H Dentalwerk Bürmoos GmbHEIA2023-07-11
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