FDA.reportPublic FDA data

OptiDisc

Primary DI
10841396118019
Brand
OptiDisc
Company
KERR CORPORATION
Model
33488
Device description
Finishing and Polishing Discs - Mandrels - For Use with Low-Speed Handpiece
Published
2016-08-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

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
10841396118019PrimaryGS10
00841396118012Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084139611801910841396118019
00841396118012008413961180128413961180120841396118012

GMDN Terms#

Term, Definition table
TermDefinition
Dental abrasive disk, reusableA dental instrument consisting of a circular flat or slightly conical sheet carrying or containing 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. It is designed to be fixed at its centre to a mandrel and intended to be used with a dental power tool handpiece (e.g., straight or contra-angle). This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store at or below 25¿C (77¿F)

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+18005377123customercare@kavokerrgroup.com

Regulatory Flags#

DUNS number
847905890
Device count
5
DM exempt
true
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

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Primary DIBrandModelCatalogPublished
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00195062145674ZenFlex CM818-36112026-02-19
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00195062145704ZenFlex CM818-36142026-02-19
00195062145711ZenFlex CM818-36152026-02-19
00195062145728ZenFlex CM818-36162026-02-19
00195062145735ZenFlex CM818-36172026-02-19
00195062145742ZenFlex CM818-36182026-02-19
00195062145247ZenFlex CM818-36022026-02-19
00195062145254ZenFlex CM818-36032026-02-19
00195062145261ZenFlex CM818-36042026-02-19

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Primary DI, Brand, Company table
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