STERI-SOL® SYSTEM

Primary DI
00854542008044
Brand
STERI-SOL® SYSTEM
Company
Anodia Systems
Model
(01)00854542008044(21)101920213030
Catalog number
ITEM #: MAK-STERI
Device description
Cutting/Cooling Fluid Delivery System for Dental High-Speed Handpiece Drills that Dispenses a cooling/cutting fluid, Steri-Sol® Solution during Dental Operative Procedures.
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
EFBHandpiece, Air-Powered, Dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EFBHandpiece, Air-Powered, DentalDental1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K882491000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K882491000CUTTING FLUID SYSTEM FOR DENTAL HIGH SPEED DRILLSSteri-Sol, Inc.1988-08-26EFB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00854542008044PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00854542008044008545420080448545420080440854542008044

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
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
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J0071600436001USA1PM 1:2Bien-Air Dental SAEFB2025-10-13
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J0071600692001USA1CA 20:1 L MICRO-SERIESBien-Air Dental SAEFB2025-10-10
J0071601136001USA1CA NOVA 1:1L MSBien-Air Dental SAEFB2025-10-10
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J021300850001WG-67 AW & H Dentalwerk Bürmoos GmbHEFB2025-03-04
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J021301090001AM-20 E BCW & H Dentalwerk Bürmoos GmbHEFB2023-07-11
J021301110001AM-25 E BC AirmotorW & H Dentalwerk Bürmoos GmbHEFB2023-07-11
J021301120001AM-25 BC Air MotorW & H Dentalwerk Bürmoos GmbHEFB2023-07-11
J021301130001AM-20 BC Air MotorW & H Dentalwerk Bürmoos GmbHEFB2023-07-11
J021301240011WE-56 T MWW & H Dentalwerk Bürmoos GmbHEFB2023-07-11
J021301250011WE-57 T MWW & H Dentalwerk Bürmoos GmbHEFB2023-07-11
J021301260011HE-43 T MW Alegra HandpieceW & H Dentalwerk Bürmoos GmbHEFB2023-07-11
J021301270011WE-56 T SD Alegra Contra-angle HandpieceW & H Dentalwerk Bürmoos GmbHEFB2023-07-11
J021301280011WE-57 T SD Alegra Contra-angle HandpieceW & H Dentalwerk Bürmoos GmbHEFB2023-07-11
J021301290011HE-43 T SD Alegra HandpieceW & H Dentalwerk Bürmoos GmbHEFB2023-07-11