Plastic Conditioner

GUDID 00190730004512

Plastic Conditioner 15ml per bottle

ORTHO TECHNOLOGY, INC.

Orthodontic bracket adhesive
Primary Device ID00190730004512
NIH Device Record Keyc75303c5-6437-43a5-9702-71bfde4d44e4
Commercial Distribution StatusIn Commercial Distribution
Brand NamePlastic Conditioner
Version Model NumberOT-PL
Company DUNS781772017
Company NameORTHO TECHNOLOGY, INC.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100190730004512 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DYHADHESIVE, BRACKET AND TOOTH CONDITIONER, 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 Date2016-09-24

Devices Manufactured by ORTHO TECHNOLOGY, INC.

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00190730084811 - Ortho Technology2024-09-26 DLR-Boone Gauge SS
00190730084828 - Ortho Technology2024-09-26 Bracket Height Gauge Alum 018
00190730084835 - Ortho Technology2024-09-26 DLR-Bracket Height Gage Alum018
00190730084842 - Ortho Technology2024-09-26 Bracket Height Gauge Alum 022
00190730084859 - Ortho Technology2024-09-26 DLR-Bracket Height Gage Alum 022
00190730084354 - Ortho Technology2024-09-25 Mosquito Hemostat
00190730084361 - Ortho Technology2024-09-25 Curved Mosquito Hemostats

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