FDA.reportPublic FDA data

Defend

Primary DI
00816577020200
Brand
Defend
Company
YOUNG MYDENT, LLC
Model
BR-9200
Published
2016-10-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

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
00816577020200PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816577020200008165770202008165770202000816577020200

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

Regulatory Flags#

DUNS number
081330555
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
90816577020395DefendVP-90032016-11-11
90816577020401DefendVP-90082016-11-11
90816577020425DefendMK-71002016-11-03
90816577020449DefendMK-71102016-11-03
90816577020463DefendMK-71202016-11-03
90816577020487DefendMK-72002016-11-07
90816577020500DefendMK-72102016-11-07
90816577020524DefendMK-72202016-11-07
90816577020548DefendMK-73002017-02-02
90816577020562DefendMK-73102016-11-07
90816577020586DefendMK-73202016-11-07
90816577020609DefendMK-74002016-10-26
90816577020623DefendVP-80082016-11-11
90816577020630DefendVP-80062016-11-11
90816577020647DefendVP-90112016-11-11
90816577020654DefendVP-90072016-11-11
90816577020661DefendVP-90102016-11-11
90816577020678DefendVP-90052016-11-11
90816577020685DefendVP-90092016-11-11
90816577020692DefendVP-90042016-11-11

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