FDA.reportPublic FDA data

Darby Dental Supply, LLC

Primary DI
00889813051115
Brand
Darby Dental Supply, LLC
Company
DARBY DENTAL SUPPLY, LLC
Model
5251886
Catalog number
5251886
Device description
TMIX C&B TIP 10:1/4:1 BLU/ORG
Published
2021-02-19
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
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
00889813051436PrimaryGS10
00889813051115Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889813051436008898130514368898130514360889813051436
00889813051115008898130511158898130511150889813051115

GMDN Terms#

Term, Definition table
TermDefinition
Dental impression material mixerA mains electricity (AC-powered) device designed for mixing to produce a dental impression material chairside immediately before application to the oral cavity of a patient during a dental procedure. It is typically used to blend a salt of alginic acid (i.e., alginate) with water (and appropriate additives if necessary) to produce a dental impression material of rapid irreversible setting. The device typically consists of an electrical mixer with a well, a container (e.g., cup) used to mix the alginate with water before placing in the mixer well, and external controls to operate the mixer.

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