FDA.report

Defend

Primary DI
00816577020163
Brand
Defend
Company
YOUNG MYDENT, LLC
Model
BR-9004
Published
2016-10-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
ELWMaterial, Impression

Product Code Classifications

CodeDeviceSpecialtyClass
ELWMaterial, ImpressionDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00816577020163PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00816577020163008165770201638165770201630816577020163

GMDN Terms

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

Regulatory Flags

DUNS number
081330555
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
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 DIBrandModelCatalogPublished
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
90816577020722DefendMK-12462016-11-11
90816577020739DefendMK-12562016-11-11
90816577022030DefendMK-12662016-11-11
00816577020217DefendMK-10002016-11-07
00816577020224DefendMK-10012016-11-07
00816577020231DefendMK-10062016-11-07
00816577020248DefendMK-10072016-11-07
00816577020255DefendMK-10082016-11-07
00816577020262DefendMK-10112016-11-07
00816577020279DefendMK-10162016-11-07

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Primary DIBrandCompanyProduct codePublished
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00850078989376SmileSet Impression Kit - Night GuardOrtho Dental Lab LLCELW2026-03-20
00860014754630Owl Impression KitOWL DENTAL LAB INCELW2026-03-05
E241AA9050Cavex CleverCast - Slow SetCavex Holland B.V.ELW2026-03-05
08719327516010Cavex CleverCast - Normal SetCavex Holland B.V.ELW2026-03-05
E241AA6050Cavex Cream FastCavex Holland B.V.ELW2026-03-04
E241AA6051Cavex Cream Fast Cavex Holland B.V.ELW2026-03-04
07630243601684AdhesiveDent4You AGELW2026-02-10
07630243601691AdhesiveDent4You AGELW2026-02-10
00850079280427CAvexHexa DentalELW2026-01-22
00850079280014One PlusHexa DentalELW2026-01-21
00085007928014One PlusHexa DentalELW2026-01-21
00850057092240HexaHexa DentalELW2026-01-21
00850057092929One PlusHexa DentalELW2026-01-21
00850057092936One PlusHexa DentalELW2026-01-21
00850057092943One PlusHexa DentalELW2026-01-21
00850057092950One PlusHexa DentalELW2026-01-21
00850057092967One PlusHexa DentalELW2026-01-21
00850057092974One PlusHexa DentalELW2026-01-21
00850057092981One PlusHexa DentalELW2026-01-21
00850079280007One PlusHexa DentalELW2026-01-21
00850079280021One PlusHexa DentalELW2026-01-21
00850079280304CavexHexa DentalELW2026-01-21
00850079280311cAVEXHexa DentalELW2026-01-21
00850079280328CavexHexa DentalELW2026-01-21
00850079280335CavexHexa DentalELW2026-01-21
00850079280342CavexHexa DentalELW2026-01-21
00850079280359CavexHexa DentalELW2026-01-21
00850057092714Hexa DentalHexa DentalELW2026-01-19
00850057092721Hexa dentalHexa DentalELW2026-01-19