FDA.reportPublic FDA data

Pure Buff Kit

Primary DI
00859611006310
Brand
Pure Buff Kit
Company
JORDCO INC
Model
PBK-S
Catalog number
PBK-S
Device description
Pure Buff Kit
Published
2020-08-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
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
00859611006310PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00859611006310008596110063108596110063100859611006310

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
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
800-752-2812accounts@jordco.com

Regulatory Flags#

DUNS number
803063981
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
00859611006112EndoringERUL-sERUL-S2020-08-08
00859611006129EndoringERULX-SERULX-S2020-08-08
00859611006259EndoringERR-SERR-S2020-08-08
00859611006266EndoringERRFR-SERRFR-S2020-08-08
00859611006273EndoringERRFL-SERRFL-S2020-08-08
00859611006570EndoringERRFRRG-SERRFRRG-S2020-08-08
00859611006587EndoringERRFLRG-SERRFLRG-S2020-08-08
00859611006631EndoringERULRG-SERULRG-S2020-08-08
00859611006648EndoringERULXRG-SERULXRG-S2020-08-08
00859611006709EndoringER2SP-EX-SER2SP-EX-S2020-08-08
00859611006723EndoringER2-EX-SER2-EX-S2020-09-07
00859611006730EnodringER-EX-SER-EX-S2020-09-07
00859611006716EndogelEG-BPEG-BP2020-08-10
00859611006006EndogelEG-sEG-S2020-08-08
00859611006020EndoringER2-SER2-S2020-08-08
00859611006037EndoringER2V-SER2V-S2020-08-08
00859611006044EndoringER2Y-SER2Y-S2020-08-08
00859611006051EndoringER2G-SER2G-S2020-08-08
00859611006068EndoringER2VX-SER2VX-S2020-08-08
00859611006075EndoringER2BX-VER2BX-S2020-08-08

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Primary DI, Brand, Company table
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00348783011999Poli-Pro DisksPREMIER DENTAL PRODUCTS COMPANYEHJ2026-05-27
00348783012019Poli-Pro DisksPREMIER DENTAL PRODUCTS COMPANYEHJ2026-05-27
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