Smart Advantage GI A1 and A2

GUDID 00858290006352

Smart Advantage GI A1 and A2 Combo kit 30 ampoules

ELEVATE ORAL CARE, LLC

Glass ionomer dental cement
Primary Device ID00858290006352
NIH Device Record Key91a600dc-0fdd-4a38-9ecf-405453736f48
Commercial Distribution StatusIn Commercial Distribution
Brand NameSmart Advantage GI A1 and A2
Version Model Number675COMB00
Company DUNS002863526
Company NameELEVATE ORAL CARE, LLC
Device Count30
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100858290006352 [Primary]
GS100858290006383 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EMACement, Dental

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-06-18
Device Publish Date2019-06-10

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