FDA.reportPublic FDA data

Darby Dental Supply, LLC

Primary DI
00889813048207
Brand
Darby Dental Supply, LLC
Company
DARBY DENTAL SUPPLY, LLC
Model
9511358
Catalog number
9511358
Device description
DRILL GATES GLIDDEN RA#5
Published
2020-11-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EKPREAMER, PULP CANAL, ENDODONTIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EKPReamer, Pulp Canal, EndodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889813048207PrimaryGS10
00889813048191Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889813048207008898130482078898130482070889813048207
00889813048191008898130481918898130481910889813048191

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.

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
Lot or batch
true
Manufacturing 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
07630049902770Reamer 21mm 055, pu: 6 pcsDiaswiss SAEKP2023-10-02
07630049990104Reamer 29mm 008, pu: 6 pcsDiaswiss SAEKP2023-10-02
07630049990128Reamer 29mm 010, pu: 6 pcsDiaswiss SAEKP2023-10-02
07630049990142Reamer 29mm 015, pu: 6 pcsDiaswiss SAEKP2023-10-02
07630049990166Reamer 29mm 020, pu: 6 pcsDiaswiss SAEKP2023-10-02
07630049990180Reamer 29mm 025, pu: 6 pcsDiaswiss SAEKP2023-10-02
07630049990203Reamer 29mm 030, pu: 6 pcsDiaswiss SAEKP2023-10-02
07630049990227Reamer 29mm 035, pu: 6 pcsDiaswiss SAEKP2023-10-02
07630049990241Reamer 29mm 040, pu: 6 pcsDiaswiss SAEKP2023-10-02
07630049990265Reamer 29mm 045, pu: 6 pcsDiaswiss SAEKP2023-10-02
07630049990289Reamer 29mm 050, pu: 6 pcsDiaswiss SAEKP2023-10-02
07630049990302Reamer 29mm 055, pu: 6 pcsDiaswiss SAEKP2023-10-02
07630049990326Reamer 29mm 060, pu: 6 pcsDiaswiss SAEKP2023-10-02
07630049990340Reamer 29mm 070, pu: 6 pcsDiaswiss SAEKP2023-10-02
07630049990364Reamer 29mm 080, pu: 6 pcsDiaswiss SAEKP2023-10-02
07630049996595Reamer 21mm 008, pu: 6 pcsDiaswiss SAEKP2023-10-02
07630049996601Reamer 21mm 010, pu: 6 pcsDiaswiss SAEKP2023-10-02
07630049996618Reamer 21mm 015, pu: 6 pcsDiaswiss SAEKP2023-10-02
07630049996625Reamer 21mm 020, pu: 6 pcsDiaswiss SAEKP2023-10-02
07630049996632Reamer 21mm 025, pu: 6 pcsDiaswiss SAEKP2023-10-02
07630049996649Reamer 21mm 030, pu: 6 pcsDiaswiss SAEKP2023-10-02
07630049996656Reamer 21mm 035, pu: 6 pcsDiaswiss SAEKP2023-10-02
07630049996663Reamer 21mm 040, pu: 6 pcsDiaswiss SAEKP2023-10-02
07630049996670Reamer 21mm 045, pu: 6 pcsDiaswiss SAEKP2023-10-02
07630049996687Reamer 21mm 050, pu: 6 pcsDiaswiss SAEKP2023-10-02
07630049996694Reamer 21mm 055, pu: 6 pcsDiaswiss SAEKP2023-10-02
07630049996700Reamer 21mm 060, pu: 6 pcsDiaswiss SAEKP2023-10-02
07630049996717Reamer 21mm 070, pu: 6 pcsDiaswiss SAEKP2023-10-02
07630049996724Reamer 21mm 080, pu: 6 pcsDiaswiss SAEKP2023-10-02
07630049996731Reamer 25mm 008, pu: 6 pcsDiaswiss SAEKP2023-10-02