PRO SEAL LIGHT CURE SEALANT

GUDID D82813302260

FIVE STAR ORTHODONTIC LABORATORY & SUPPLY INC

Dental unfilled resin sealant/coating
Primary Device IDD82813302260
NIH Device Record Key4d91d500-7ed3-435f-99b7-a29562c786c0
Commercial Distribution StatusIn Commercial Distribution
Brand NamePRO SEAL LIGHT CURE SEALANT
Version Model Number1330226
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
HIBCCD82813302260 [Primary]

FDA Product Code

EBDCoating, Filling Material, Resin

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-09-24

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