TASTES GREAT

GUDID 00190730004376

Alginate Flavoring Pina Colada 2 fl oz per bottle

ORTHO TECHNOLOGY, INC.

Alginate dental impression material
Primary Device ID00190730004376
NIH Device Record Key378c96d3-8704-40b1-8a13-93f9eecbf45c
Commercial Distribution StatusIn Commercial Distribution
Brand NameTASTES GREAT
Version Model Number250-108
Company DUNS781772017
Company NameORTHO TECHNOLOGY, INC.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100190730004376 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ELWMATERIAL, IMPRESSION

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-24

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00190730004390Alginate Flavoring Orange 2 fl oz per bottle
00190730004383Alginate Flavoring Cotton Cndy 2 fl oz per bottle
00190730004376Alginate Flavoring Pina Colada 2 fl oz per bottle
00190730004369Alginate Flavoring Raspberry 2 fl oz per bottle
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