FDA.reportPublic FDA data

Darby Dental Supply, LLC

Primary DI
00889813048276
Brand
Darby Dental Supply, LLC
Company
DARBY DENTAL SUPPLY, LLC
Model
9511402
Catalog number
9511402
Device description
PEESO REAMERS RA#2 32MM
Published
2020-11-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
DZADRILL, DENTAL, INTRAORAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZADrill, Dental, IntraoralDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889813048283PrimaryGS10
00889813048276Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889813048283008898130482838898130482830889813048283
00889813048276008898130482768898130482760889813048276

GMDN Terms#

Term, Definition table
TermDefinition
Endodontic enlarger, reusableA manual dental instrument designed to be used to access the root canal and to enlarge the opening of the coronal portion of the root canal. 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
6
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
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
06947600328834Pilot Drill,BLT,Φ2.2mm/Φ5.0mm,L5mm,GuidedBIO CONCEPT Co., Ltd.DZA2026-05-27
06947600328841Pilot Drill,BLT,Φ2.2mm/Φ5.0mm,L8mm,GuidedBIO CONCEPT Co., Ltd.DZA2026-05-27
06947600328858Pilot Drill,BLT,Φ2.2mm/Φ5.0mm,L10mm,GuidedBIO CONCEPT Co., Ltd.DZA2026-05-27
06947600328865Pilot Drill,BLT,Φ2.2mm/Φ5.0mm,L12mm,GuidedBIO CONCEPT Co., Ltd.DZA2026-05-27
06947600328872Pilot Drill,BLT,Φ2.2mm/Φ5.0mm,L14mm,GuidedBIO CONCEPT Co., Ltd.DZA2026-05-27
06947600328889Pilot Drill,BLT,Φ2.2mm/Φ5.0mm,L16mm,GuidedBIO CONCEPT Co., Ltd.DZA2026-05-27
06947600328896Expander Drill,BLT,Φ2.8mm/Φ5.0mm,L8mm,GuidedBIO CONCEPT Co., Ltd.DZA2026-05-27
06947600328902Expander Drill,BLT,Φ2.8mm/Φ5.0mm,L10mm,GuidedBIO CONCEPT Co., Ltd.DZA2026-05-27
06947600328919Expander Drill,BLT,Φ2.8mm/Φ5.0mm,L12mm,GuidedBIO CONCEPT Co., Ltd.DZA2026-05-27
06947600328926Expander Drill,BLT,Φ2.8mm/Φ5.0mm,L14mm,GuidedBIO CONCEPT Co., Ltd.DZA2026-05-27
06947600328933Expander Drill,BLT,Φ2.8mm/Φ5.0mm,L16mm,GuidedBIO CONCEPT Co., Ltd.DZA2026-05-27
06947600328940Expander Drill,BLT,Φ3.5mm/Φ5.0mm,L8mm,GuidedBIO CONCEPT Co., Ltd.DZA2026-05-27
06947600328957Expander Drill,BLT,Φ3.5mm/Φ5.0mm,L10mm,GuidedBIO CONCEPT Co., Ltd.DZA2026-05-27
06947600328964Expander Drill,BLT,Φ3.5mm/Φ5.0mm,L12mm,GuidedBIO CONCEPT Co., Ltd.DZA2026-05-27
06947600328971Expander Drill,BLT,Φ3.5mm/Φ5.0mm,L14mm,GuidedBIO CONCEPT Co., Ltd.DZA2026-05-27
06947600328988Expander Drill,BLT,Φ3.5mm/Φ5.0mm,L16mm,GuidedBIO CONCEPT Co., Ltd.DZA2026-05-27
06947600328995Expander Drill,BLT,Φ4.2mm/Φ5.0mm,L8mm,GuidedBIO CONCEPT Co., Ltd.DZA2026-05-27
06947600329008Expander Drill,BLT,Φ4.2mm/Φ5.0mm,L10mm,GuidedBIO CONCEPT Co., Ltd.DZA2026-05-27
06947600329015Expander Drill,BLT,Φ4.2mm/Φ5.0mm,L12mm,GuidedBIO CONCEPT Co., Ltd.DZA2026-05-27
06947600329022Expander Drill,BLT,Φ4.2mm/Φ5.0mm,L14mm,GuidedBIO CONCEPT Co., Ltd.DZA2026-05-27
06947600329039Expander Drill,BLT,Φ4.2mm/Φ5.0mm,L16mm,GuidedBIO CONCEPT Co., Ltd.DZA2026-05-27
06947600329046Profile Drill,BLT,Φ3.3mm, L33mm,GuidedBIO CONCEPT Co., Ltd.DZA2026-05-27
06947600329060Profile Drill,BLT,Φ4.1mm, L33mm,GuidedBIO CONCEPT Co., Ltd.DZA2026-05-27
06947600329084Profile Drill,BLT,Φ4.8mm, L33mm,GuidedBIO CONCEPT Co., Ltd.DZA2026-05-27
07899878064985NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.DZA2026-03-18
07899878064992NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.DZA2026-03-18
07899878065005NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.DZA2026-03-18
07899878065012NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.DZA2026-03-18
07899878065029NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.DZA2026-03-18
07899878065036NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.DZA2026-03-18