TRANSBOND LOLLYPOPS ETCH/PRIMER-100 PACK

GUDID D8281330605

FIVE STAR ORTHODONTIC LABORATORY & SUPPLY INC

Orthodontic bracket adhesive
Primary Device IDD8281330605
NIH Device Record Keydfa2d6f6-95c8-4c09-98de-c94d64e23caa
Commercial Distribution StatusIn Commercial Distribution
Brand NameTRANSBOND LOLLYPOPS ETCH/PRIMER-100 PACK
Version Model Number1330605
Company DUNS113352686
Company NameFIVE STAR ORTHODONTIC LABORATORY & SUPPLY INC
Device Count100
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
HIBCCD8281330605 [Primary]
HIBCCD82813306056 [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

Devices Manufactured by FIVE STAR ORTHODONTIC LABORATORY & SUPPLY INC

D82850001900 - Twin Block2024-10-21
D82853004020 - Rickonator2024-10-21
D82851001560 - Bioliner Plus2023-02-20
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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.