Premium Tray 1121312

GUDID D8451121312

Cold-cured acrylic resin, White, 11.3 kg

Denplus Inc

Dental impression tray material
Primary Device IDD8451121312
NIH Device Record Key403871dc-5282-4bf5-940c-5b1577beff91
Commercial Distribution StatusIn Commercial Distribution
Brand NamePremium Tray
Version Model Number1121312
Catalog Number1121312
Company DUNS202016064
Company NameDenplus Inc
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusMR Safe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD8451121312 [Primary]

FDA Product Code

EBHMaterial, Impression Tray, Resin

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-09-29
Device Publish Date2021-09-21

On-Brand Devices [Premium Tray]

D8451121315Cold-Cured Acrylic Resin, Blue, 11.3 kg
D8451121314Cold-cured acrylic resin, Pink, 11.3 kg
D8451121313Cold-cured acrylic resin, Yellow, 11.3 kg
D8451121312Cold-cured acrylic resin, White, 11.3 kg
D8451121215Cold-cured acrylic resin, Blue, 2.3 kg
D8451121214Cold-cured acrylic resin, Pink, 2.3 kg
D8451121213Cold-cured acrylic resin, Yellow, 2.3 kg
D8451121212Cold-cured acrylic resin, White, 2.3 kg
D8451121115Cold-cured acrylic resin, Blue, 454 g
D8451121114Cold-cured acrylic resin, Pink, 454 g
D8451121113Cold-cured acrylic resin, Yellow, 454 g
D8451121112Cold-cured acrylic resin, White, 454 g

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