FDA.report

WaterlineX®

Primary DI
00854542008167
Brand
WaterlineX®
Company
Anodia Systems
Model
(01)854542008167(10)204008
Catalog number
ITEM #: MAK-1806
Device description
WaterlineX® is a closed pressurized dental bottle system capable of supplying dental unit water, a cleaning solution or pressurized air to the dental unit waterlines. The system can be used with solutions to clean the dental unit waterlines by air purging and/or injecting a cleaning solution (ITEM #: MAK-1806). System includes a heavy duty dental unit water bottle.
Published
2023-08-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
EIAUnit, Operative Dental

Product Code Classifications

CodeDeviceSpecialtyClass
EIAUnit, Operative DentalDental1

Premarket Submissions

SubmissionSupplement
K023896000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K023896000C-1890Anodia Systems2003-06-19EIA

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00854542008167PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00854542008167008545420081678545420081670854542008167

GMDN Terms

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

Contacts

PhoneEmail
866-246-2548INFO@ANODIASYSTEMS.COM

Regulatory Flags

DUNS number
030080456
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00854542008037PRO-KLEEN854542008037MAK-19102023-08-19
00854542008211Zoral00854542008372item # MAK-13102023-08-19
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

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