PORCELAIN ETCH AND BARRIER GEL

GUDID D82813309000

FIVE STAR ORTHODONTIC LABORATORY & SUPPLY INC

Orthodontic bracket adhesive
Primary Device IDD82813309000
NIH Device Record Key53971d9c-6fc0-4433-9d1f-c1d6d04487df
Commercial Distribution StatusIn Commercial Distribution
Brand NamePORCELAIN ETCH AND BARRIER GEL
Version Model Number1330900
Company DUNS113352686
Company NameFIVE STAR ORTHODONTIC LABORATORY & SUPPLY INC
Device Count1
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 Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD82813309000 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EIHPowder, Porcelain

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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