FDA.reportPublic FDA data

Darby Dental Supply, LLC

Primary DI
00889813041918
Brand
Darby Dental Supply, LLC
Company
DARBY DENTAL SUPPLY, LLC
Model
9544386
Catalog number
9544386
Device description
FINGER PLUGGERS 25MM #35
Published
2022-05-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EKRPLUGGER, ROOT CANAL, ENDODONTIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EKRPlugger, Root Canal, EndodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889813041925PrimaryGS10
00889813041918Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889813041925008898130419258898130419250889813041925
00889813041918008898130419188898130419180889813041918

GMDN Terms#

Term, Definition table
TermDefinition
Rotary/reciprocating endodontic spreader, non-sterileA non-sterile dental endpiece designed to be attached to a rotary or reciprocating dental power tool handpiece to compress filling materials in a root canal, mainly in a lateral direction. It is a thin rod made of metal and its working end is typically helicoidal or circular. This is a single-use 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
6
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
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 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
00348783009002Premier PluggersPREMIER DENTAL PRODUCTS COMPANYEKR2026-04-30
00348783009019Premier PluggersPREMIER DENTAL PRODUCTS COMPANYEKR2026-04-30
00348783009026Premier PluggersPREMIER DENTAL PRODUCTS COMPANYEKR2026-04-30
00348783009033Premier PluggersPREMIER DENTAL PRODUCTS COMPANYEKR2026-04-30
00348783009057Premier PluggersPREMIER DENTAL PRODUCTS COMPANYEKR2026-04-30
00348783008975Premier PluggersPREMIER DENTAL PRODUCTS COMPANYEKR2026-04-29
00348783008982Premier PluggersPREMIER DENTAL PRODUCTS COMPANYEKR2026-04-29
00348783008999Premier PluggersPREMIER DENTAL PRODUCTS COMPANYEKR2026-04-29
00348783009125Premier PluggersPREMIER DENTAL PRODUCTS COMPANYEKR2026-04-29
00348783009132Premier PluggersPREMIER DENTAL PRODUCTS COMPANYEKR2026-04-29
00348783009149Premier PluggersPREMIER DENTAL PRODUCTS COMPANYEKR2026-04-29
00348783008913Premier PluggersPREMIER DENTAL PRODUCTS COMPANYEKR2026-04-28
00348783008920Premier PluggersPREMIER DENTAL PRODUCTS COMPANYEKR2026-04-28
00348783008937Premier PluggersPREMIER DENTAL PRODUCTS COMPANYEKR2026-04-28
00348783008944Premier PluggersPREMIER DENTAL PRODUCTS COMPANYEKR2026-04-28
00348783008951Premier PluggersPREMIER DENTAL PRODUCTS COMPANYEKR2026-04-28
00348783009088Premier PluggersPREMIER DENTAL PRODUCTS COMPANYEKR2026-04-28
00348783009095Premier PluggersPREMIER DENTAL PRODUCTS COMPANYEKR2026-04-28
00348783009101Premier PluggersPREMIER DENTAL PRODUCTS COMPANYEKR2026-04-28
00348783009118Premier PluggersPREMIER DENTAL PRODUCTS COMPANYEKR2026-04-28
E89616970207E0SCHWERTA. Schweickhardt GmbH & Co. KGEKR2025-10-14
E89616970307E0SCHWERTA. Schweickhardt GmbH & Co. KGEKR2025-10-14
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