Premium Tray 1121213

GUDID D8451121213

Cold-cured acrylic resin, Yellow, 2.3 kg

Denplus Inc

Dental impression tray material
Primary Device IDD8451121213
NIH Device Record Keya501c059-d7c1-44b1-8333-7e5fea428782
Commercial Distribution StatusIn Commercial Distribution
Brand NamePremium Tray
Version Model Number1121213
Catalog Number1121213
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
HIBCCD8451121213 [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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