FDA.report

Zoral Scaler Solution®

Primary DI
00854542008198
Brand
Zoral Scaler Solution®
Company
Anodia Systems
Model
MAK-Z1
Device description
Lubricating Coolant Irrigating Solution used with Dental Irrigation Systems and Ultrasonic Scalers During Dental Hygiene Scaling Procedures. 1 Bottle Package (ITEM #MAK-Z1)
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
true

Related Records

Contact Domains

Product Codes

CodeName
EFBHandpiece, Air-Powered, Dental

Product Code Classifications

CodeDeviceSpecialtyClass
EFBHandpiece, Air-Powered, DentalDental1

Premarket Submissions

SubmissionSupplement
K925378000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K925378000STERI-SOL SOLUTION, MODIFICATIONAnodia Systems1993-07-22EFB

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00854542008198PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00854542008198008545420081988545420081980854542008198

GMDN Terms

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

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
true
Expiration date on label
true
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
00854542008167WaterlineX®(01)854542008167(10)204008ITEM #: MAK-18062023-08-06
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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