TRANSBOND LOLLYPOPS ETCH/PRIMER-20 PACK

GUDID D8281330604

FIVE STAR ORTHODONTIC LABORATORY & SUPPLY INC

Orthodontic bracket adhesive
Primary Device IDD8281330604
NIH Device Record Key6058b85b-c284-4663-a527-64fa14d98428
Commercial Distribution StatusIn Commercial Distribution
Brand NameTRANSBOND LOLLYPOPS ETCH/PRIMER-20 PACK
Version Model Number1330604
Company DUNS113352686
Company NameFIVE STAR ORTHODONTIC LABORATORY & SUPPLY INC
Device Count20
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
HIBCCD8281330604 [Primary]
HIBCCD82813306043 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KLEAgent, Tooth Bonding, Resin

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 Date2016-09-27

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D8281330003 - FUJI SC BAND PASTE PAK2018-07-06
D8281330121 - FUJI LC BAND AUTOMIX2018-07-06
D8281330171 - ULTRA BAND LOK CLEAR2018-07-06
D8281330205 - LIGHT BOND PASTE TIPS2018-07-06

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