FDA.reportPublic FDA data

Zoral Scaler Solution®

Primary DI
00854542008204
Brand
Zoral Scaler Solution®
Company
Anodia Systems
Model
MAK-Z4
Device description
Lubricating Coolant Irrigating Solution used with Dental Irrigation Systems and Ultrasonic Scalers During Dental Hygiene Scaling Procedures. 4 Bottle Package (ITEM #MAK-Z4)
Published
2023-08-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

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
K925378000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K925378000STERI-SOL SOLUTION, MODIFICATIONAnodia Systems1993-07-22EFB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00854542008204PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00854542008204008545420082048545420082040854542008204

GMDN Terms#

Term, Definition table
TermDefinition
Dental scaling solutionA liquid substance used in dentistry to soften and partially solubilize a dental calculus (a hard deposit that forms on the teeth) before scaling mechanically so that less force is required, especially when teeth are loose. It will typically contain acid as a solvent (e.g., hydrochloric) and include other elements (e.g., iodine and excipients). After application, this device cannot be reused.

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
Manufacturing date on label
true
Expiration date on label
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
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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