FDA.reportPublic FDA data

Darby Dental Supply, LLC

Primary DI
00889813054512
Brand
Darby Dental Supply, LLC
Company
DARBY DENTAL SUPPLY, LLC
Model
5252796
Catalog number
5252796
Device description
PVS IMP MAT PUTTY 300ML FS UN
Published
2021-09-18
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
ELWMATERIAL, IMPRESSION

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ELWMaterial, ImpressionDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889813054512PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889813054512008898130545128898130545120889813054512

GMDN Terms#

Term, Definition table
TermDefinition
Silicone dental impression materialAn elastomeric, polysiloxane-based material capable of reacting to form a rubber-like substance suitable to reproduce the structure of a patient's teeth and gums, or other oral anatomy, after being placed on an impression tray and inserted into the mouth. 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
1
Lot or batch
true
Expiration 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
08800024205816Delikit 7.0 Light Body FastSherpakoreaELW2023-01-16
08800024205908Delikit 7.0 Extra Light Body FastSherpakoreaELW2023-01-16
08800024204420Delikit 7.0 Light Body RegularSherpakoreaELW2023-01-12
08800024204451Delikit 3.0 Light BodySherpakoreaELW2023-01-12
08800024204468Delikit 3.0 Light Body FastSherpakoreaELW2023-01-12
08800024204475Delikit 3.0 Extra Light Body FastSherpakoreaELW2023-01-12
08800024205397Delikit Putty Eco Fast SetSherpakoreaELW2023-01-12
08800024203805Delikit 3.0 Light BodySherpakoreaELW2022-09-15
08800024203997Delikit 3.0 Light Body FastSherpakoreaELW2022-09-15
07640181478934AFFINISColtène/Whaledent AGELW2022-03-27
07640181478958AFFINISColtène/Whaledent AGELW2022-03-27
07640181478972AFFINISColtène/Whaledent AGELW2022-03-27
07640181479030AFFINISColtène/Whaledent AGELW2022-03-27
07640181479054AFFINISColtène/Whaledent AGELW2022-03-27
07640181479061AFFINISColtène/Whaledent AGELW2022-03-27
07640181479115AFFINISColtène/Whaledent AGELW2022-03-27
07640181479146AFFINISColtène/Whaledent AGELW2022-03-27
07640181479153AFFINISColtène/Whaledent AGELW2022-03-27
07640181479160AFFINISColtène/Whaledent AGELW2022-03-27
07640181479177AFFINISColtène/Whaledent AGELW2022-03-27
07640181479214AFFINISColtène/Whaledent AGELW2022-03-27
07640181479238AFFINISColtène/Whaledent AGELW2022-03-27
07640181479245AFFINISColtène/Whaledent AGELW2022-03-27
07640181479290AFFINISColtène/Whaledent AGELW2022-03-27
07640181479306AFFINISColtène/Whaledent AGELW2022-03-27
07640181479313AFFINISColtène/Whaledent AGELW2022-03-27
07640181479481AFFINIS BLACKColtène/Whaledent AGELW2022-03-27
07640181479528AFFINIS BLACKColtène/Whaledent AGELW2022-03-27
07640181479597PRESIDENT The OriginalColtène/Whaledent AGELW2022-02-11
07640181479603PRESIDENT The OriginalColtène/Whaledent AGELW2022-02-11