FDA.reportPublic FDA data

Darby Dental Supply, LLC

Primary DI
00889813046388
Brand
Darby Dental Supply, LLC
Company
DARBY DENTAL SUPPLY, LLC
Model
9510423
Catalog number
9510423
Device description
MANDRELS RA FOR F & P DISCS
Published
2020-07-02
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
00889813046395PackageGS110In Commercial Distribution
00889813046388PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889813046395008898130463958898130463950889813046395
00889813046388008898130463888898130463880889813046388

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(516)688-6800Robyn.livingston@darby.com

Regulatory Flags#

DUNS number
825137818
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00889813067970Darby Dental Supply, LLC95377462026-03-22
00889813067987Darby Dental Supply, LLC95377502026-03-22
00889813067994Darby Dental Supply, LLC525879552587952026-02-12
00889813068007Darby Dental Supply, LLC525879652587962026-02-12
00889813068021Darby Dental Supply, LLC525879752587972026-02-12
00889813068038Darby Dental Supply, LLC525879852587982026-02-12
00889813068045Darby Dental Supply, LLC525879952587992026-02-12
00889813068052Darby Dental Supply, LLC525879052587902026-02-12
00889813068069Darby Dental Supply, LLC525879152587912026-02-12
00889813068076Darby Dental Supply, LLC525879252587922026-02-12
00889813068083Darby Dental Supply, LLC525879352587932026-02-12
00889813068090Darby Dental Supply, LLC525879452587942026-02-12
00889813048566Darby Dental Supply, LLC943020394302032022-07-18
00889813048580Darby Dental Supply, LLC943020494302042022-07-18
00889813048610Darby Dental Supply, LLC943020594302052022-07-18
00889813048672Darby Dental Supply, LLC943021094302102022-07-18
00889813048696Darby Dental Supply, LLC943021194302112022-07-18
00889813048719Darby Dental Supply, LLC943021294302122022-07-18
00889813048443Darby Dental Supply, LLC943020294302022022-07-18
00889813048511Darby Dental Supply, LLC943020194302012022-07-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00348783011920Poli-Pro DisksPREMIER DENTAL PRODUCTS COMPANYEHJ2026-05-27
00348783011975Poli-Pro DisksPREMIER DENTAL PRODUCTS COMPANYEHJ2026-05-27
00348783011982Poli-Pro DisksPREMIER DENTAL PRODUCTS COMPANYEHJ2026-05-27
00348783011999Poli-Pro DisksPREMIER DENTAL PRODUCTS COMPANYEHJ2026-05-27
00348783012019Poli-Pro DisksPREMIER DENTAL PRODUCTS COMPANYEHJ2026-05-27
07615208291643OptraGlossIVOCLAR VIVADENT AKTIENGESELLSCHAFTEHJ2026-04-23
306058610117793M™ Sof-Lex™3M COMPANYEHJ2026-04-17
306058610117933M™ Sof-Lex™3M COMPANYEHJ2026-04-17
306058610217543M™ Sof-Lex™3M COMPANYEHJ2026-04-17
306058610217783M™ Sof-Lex™3M COMPANYEHJ2026-04-17
306058610217923M™ Sof-Lex™3M COMPANYEHJ2026-04-17
306058610262163M™ Sof-Lex™3M COMPANYEHJ2026-04-17
306058610262303M™ Sof-Lex™3M COMPANYEHJ2026-04-17
306058610262543M™ Sof-Lex™3M COMPANYEHJ2026-04-17
306058610262783M™ Sof-Lex™3M COMPANYEHJ2026-04-17
306058610262923M™ Sof-Lex™3M COMPANYEHJ2026-04-17
306058610263393M™ Sof-Lex™3M COMPANYEHJ2026-04-17
306058610263533M™ Sof-Lex™3M COMPANYEHJ2026-04-17
306058610263773M™ Sof-Lex™3M COMPANYEHJ2026-04-17
306058610263913M™ Sof-Lex™3M COMPANYEHJ2026-04-17
306058610264383M™ Sof-Lex™3M COMPANYEHJ2026-04-17
306058610264523M™ Sof-Lex™3M COMPANYEHJ2026-04-17
306058610264763M™ Sof-Lex™3M COMPANYEHJ2026-04-17
306058610264903M™ Sof-Lex™3M COMPANYEHJ2026-04-17
306058610265133M™ Sof-Lex™3M COMPANYEHJ2026-04-17
306058610265373M™ Sof-Lex™3M COMPANYEHJ2026-04-17
306058610265513M™ Sof-Lex™3M COMPANYEHJ2026-04-17
306058610265753M™ Sof-Lex™3M COMPANYEHJ2026-04-17
306058610685683M™ Sof-Lex™3M COMPANYEHJ2026-04-17
306058610685753M™ Sof-Lex™3M COMPANYEHJ2026-04-17