TRANSBOND PRIMER

GUDID D82813306070

FIVE STAR ORTHODONTIC LABORATORY & SUPPLY INC

Orthodontic bracket adhesive Orthodontic bracket adhesive
Primary Device IDD82813306070
NIH Device Record Key654a8207-9ade-4350-8a55-bad55a71b8cb
Commercial Distribution StatusIn Commercial Distribution
Brand NameTRANSBOND PRIMER
Version Model Number1330607
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
HIBCCD82813306070 [Primary]

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

Devices Manufactured by FIVE STAR ORTHODONTIC LABORATORY & SUPPLY INC

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D82852000920 - Vivos mmRNA2021-11-29
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
D8281330206 - SKINNY NOSE LIGHT BOND PASTE TIPS2018-07-06
D82813302070 - LIGHT BOND SYRINGE2018-07-06

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