FDA.reportPublic FDA data

Zubler USA

Primary DI
D815PKDZLZ0
Brand
Zubler USA
Company
OPA DENTAL LLC
Model
PKDZLZ
Catalog number
PKDZLZ
Device description
Chairside rotary tool adjustment kit for crowns. Kit contains discs (LXZW), points (NCFW), and burs (HGDH)
Published
2020-06-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
EHJDisk, Abrasive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EHJDisk, AbrasiveDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D815PKDZLZ0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental abrasive disk, single-useA dental instrument consisting of a circular flat or slightly conical sheet, which may carry or contain an abrasive, intended to perform a circular and/or oscillatory motion for polishing and finishing a cavity preparation and/or for cutting or polishing dental restorations (e.g., dentures, fillings, crowns). It is designed to be fixed at its centre to a laboratory mandrel or lathe, and/or intended to be used with a dental power tool handpiece (e.g., straight or contra-angle). This is a single-use device.

Sterilization Methods#

Method table
Method
Dry Heat Sterilization

Regulatory Flags#

DUNS number
053308044
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D815VCR9814DARK0VEICRRVCR9814DARKVCR9814DARK2024-06-10
D815VCR9814LIGHT0VEICRRVCR9814LIGHTVCR9814LIGHT2024-06-10
D815VCR9820DARK0VEICRRVCR9820DARKVCR9820DARK2024-06-10
D815VCR9820LIGHT0VEICRRVCR9820LIGHTVCR9820LIGHT2024-06-10
D815OPAFILL4DO0OPAOPAFILL4DOOPAFILL4DO2023-12-14
D815OPAFILL4DR0OPAOPAFILL4DROPAFILL4DR2023-12-14
D815OPAFILL4P20OPAOPAFILL4P2OPAFILL4P22023-12-14
D815OPAFLOW2DO0OPAOPAFLOW2DOOPAFLOW2DO2023-12-14
D815OPAFLOW2DR0OPAOPAFLOW2DROPAFLOW2DR2023-12-14
D815OPAFLOW2LR0OPAOPAFLOW2LROPAFLOW2LR2023-12-14
D815OPAFLOW2LT0OPAOPAFLOW2LTOPAFLOW2LT2023-12-14
D815OPAFLOW2P10OPAOPAFLOW2P1OPAFLOW2P12023-12-14
D815OPAFLOW2P20OPAOPAFLOW2P2OPAFLOW2P22023-12-14
D815OPAFLOW2W0OPAOPAFLOW2WOPAFLOW2W2023-12-14
PMMA9825CLEAR0LunaPMMA9825CLEARPMMA9825CLEAR2017-04-18
PMMA9520A00LunaPMMA9520A0PMMA9520A02017-04-18
D815PMMA10020A20LunaPMMA10020A2PMMA10020A22017-02-11
D815PMMA10020B10LunaPMMA10020B1PMMA10020B12017-02-11
D815PMMA4019A01LunaPMMA4019A0PMMA4019A02017-02-11
D815PMMA4019A11LunaPMMA4019A1PMMA4019A12017-02-11

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Primary DI, Brand, Company table
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00348783012019Poli-Pro DisksPREMIER DENTAL PRODUCTS COMPANYEHJ2026-05-27
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