FDA.reportPublic FDA data

Darby Dental Supply, LLC

Primary DI
00889813057421
Brand
Darby Dental Supply, LLC
Company
DARBY DENTAL SUPPLY, LLC
Model
9430704
Catalog number
9430704
Device description
T-STYLE MIX TIPS PINK 5.4MM
Published
2022-05-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EIDSYRINGE, RESTORATIVE AND IMPRESSION MATERIAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EIDSyringe, Restorative And Impression MaterialDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889813057438PrimaryGS10
00889813057421Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889813057438008898130574388898130574380889813057438
00889813057421008898130574218898130574210889813057421

GMDN Terms#

Term, Definition table
TermDefinition
Dental material mixing nozzle, non-sterileA non-sterile device designed for mixing inactive compounds during a dental procedure to produce a functional dental restorative/impression material which may be applied directly to the oral cavity/teeth of the patient or used for some other dental application. It is nozzle-shaped and has an integral mixing mechanism (e.g., spiralled channels). It is attached to the end of a cartridge consisting of two tubes so that the compounds are mixed as they are expressed simultaneously from the tubes through the nozzle. 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
48
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
10889813067960Darby Dental Supply, LLC95531292025-07-12
10889813067649Darby Dental Supply, LLC52584552025-07-02
10889813067663Darby Dental Supply, LLC95531332025-07-02
10889813067670Darby Dental Supply, LLC95531342025-07-02
10889813067687Darby Dental Supply, LLC95531352025-07-02
10889813067694Darby Dental Supply, LLC95531362025-07-02
10889813067700Darby Dental Supply, LLC95531372025-07-02
10889813067717Darby Dental Supply, LLC95531392025-07-02
10889813067724Darby Dental Supply, LLC95531382025-07-02
10889813067731Darby Dental Supply, LLC95531402025-07-02
10889813067755Darby Dental Supply, LLC95531412025-07-02
10889813067762Darby Dental Supply, LLC95531422025-07-02
10889813067779Darby Dental Supply, LLC95531432025-07-02
10889813067786Darby Dental Supply, LLC95531442025-07-02
10889813067793Darby Dental Supply, LLC95531452025-07-02
10889813067809Darby Dental Supply, LLC95531462025-07-02
10889813067816Darby Dental Supply, LLC95531472025-07-02
10889813067823Darby Dental Supply, LLC95531482025-07-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840481135309MICROPRIMEZest Anchors, LLCEID2026-03-10
00840479201115CR MARK II SYRINGERELIANCE ORTHODONTIC PRODUCTS INCEID2026-02-27
00304040194782Henry ScheinHENRY SCHEIN, INC.EID2026-01-20
00304040194799Henry ScheinHENRY SCHEIN, INC.EID2026-01-20
00304040194805Henry ScheinHENRY SCHEIN, INC.EID2026-01-20
00371347019889Advance Dental ProductsThe Atlanta Dental Supply CompanyEID2025-12-30
00841336104877Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEID2025-12-22
00841336104891Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEID2025-12-22
00841336104907Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEID2025-12-22
00841336104914Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEID2025-12-22
00810126504357Essentials by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCEID2025-12-16
00810126504388Essentials by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCEID2025-12-16
00371347017786Advance Dental ProductsThe Atlanta Dental Supply CompanyEID2025-11-18
08800017902265DX-MixerDXM CO., LTDEID2025-09-29
20840326424302DefendYoung Innovations, Inc.EID2025-09-05
00883205032041ExperTempULTRADENT PRODUCTS, INC.EID2025-08-23
E217172261Mixing TipsKettenbach GmbH & Co. KGEID2025-08-14
E239D49701X41Mixing tipsDreve Dentamid GmbHEID2025-08-13
00195062154119Kerr RestorativesKerr CorporationEID2025-08-08
00195062154126Kerr RestorativesKerr CorporationEID2025-08-08
00195062154133Kerr RestorativesKerr CorporationEID2025-08-08
00195062154140Kerr RestorativesKerr CorporationEID2025-08-08
00195062154157Kerr RestorativesKerr CorporationEID2025-08-08
00195062154164Kerr RestorativesKerr CorporationEID2025-08-08
E239D496041TipsDreve Dentamid GmbHEID2025-07-21
E239D49701X61Mixing tipsDreve Dentamid GmbHEID2025-07-18
00359883007201EVANESCEDEN-MAT HOLDINGS, LLCEID2025-05-30
00813909013350Dental Cartridge DispenserNOVABONE PRODUCTS, LLCEID2025-04-25
E217150221Application TipsKettenbach GmbH & Co. KGEID2025-04-03
E217150231Application TipsKettenbach GmbH & Co. KGEID2025-04-03