InVu Readi-Base Brackets

GUDID 00192029003336

Roth LR 1st Bicuspid w / Hk; MBT LR 2nd Bicuspid w / Hk -17 Torque, 0 Tip, Without Vertical Slot, Bondable 0.46mm (.018")

TP ORTHODONTICS INC

Orthodontic bracket, ceramic
Primary Device ID00192029003336
NIH Device Record Keyb657fd19-630f-4a16-bf00-b1894d891a9a
Commercial Distribution StatusIn Commercial Distribution
Brand NameInVu Readi-Base Brackets
Version Model Number297-289MRX
Company DUNS005432299
Company NameTP ORTHODONTICS 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 Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100192029003336 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NJMBracket, ceramic, orthodontic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-03-11
Device Publish Date2019-02-14

On-Brand Devices [InVu Readi-Base Brackets]

00192029005682Lower Left Cuspid Without Hook -6 Torque, +3 Tip Without Vertical Slot Bondable 0.46mm (.018")
00192029005620Lower Right Cuspid With Hook 0 Torque, +3 Tip, 0.56 mm (.022") Without Vertical Slot, Bo
00192029005583Lower Left Cuspid With Hook 0 Torque, +3 Tip, 0.56 mm (.022") Without Vertical Slot, Bondable
00192029005545Lower Right Cuspid With Hook 0 Torque, +3 Tip 0.46 mm (.018") Without Vertical Slot, Bondable
00192029005507Lower Left Cuspid With Hook 0 Torque, +3 Tip, 0.46 mm (.018") Without Vertical Slot, Bondable
00192029005460Lower Right Cuspid With Hook -11 Torque, +6 Tip, Bondable 0.56mm (.022")
00192029005422Lower Left Cuspid With Hook -11 Torque, +6 Tip, Bondable 0.56mm (.022")
00192029005385Lower Right Cuspid With Hook -11 Torque, +6 Tip, Bondable 0.46mm (.018")
00192029005347Lower Left Cuspid With Hook -11 Torque, +6 Tip, Bondable 0.46mm (.018")
00192029005309Upper Right Cuspid With Hook +0 Torque, +8 Tip Without Vertical Slot, Bondable 0.56mm (.022")
00192029005262Upper Left Cuspid With Hook +0 Torque, +8 Tip Without Vertical Slot, Bondable 0.56mm (.022")
00192029005224Upper Right Cuspid With Hook +0 Torque, +8 Tip Without Vertical Slot, Bondable 0.46mm (.018")
00192029005187Upper Left Cuspid With Hook +0 Torque, +8 Tip Without Vertical Slot, Bondable 0.46mm (.018")
00192029005149Upper & Lower 5-5 Cuspid /Bicuspid With Hooks, 0.56 mm (.022")
00192029005101Upper & Lower 5-5 Cuspid /Bicuspid With Hooks, 0.46 mm (.018")
00192029005064Upper 5-5 Cuspid/Bicuspid With Hooks, 0.56 mm (.022")
00192029005026Upper 5-5 Cuspid/Bicuspid With Hooks, 0.46 mm (.018")
00192029004982Upper & Lower 5-5 Cuspid/Bicuspid With Hooks 0.56mm (.022")
00192029004944Upper & Lower 5-5 Cuspid/Bicuspid With Hooks 0.46mm (.018")
00192029004906Upper 5-5 Cuspid/Bicuspid With Hooks 0.56mm (.022")
00192029004869Upper 5-5 Cuspid/Bicuspid With Hooks 0.46mm (.018")
00192029004821Upper & Lower 5-5 Cuspid/Bicuspid With Hooks 0.56mm (.022")
00192029004807Upper & Lower 5-5 Cuspid/Bicuspid With Hooks 0.46mm (.018")
00192029004784Upper 5-5 Cuspid/Bicuspid With Hooks 0.56mm (.022")
00192029004760Upper 5-5 Cuspid/Bicuspid With Hooks 0.46mm (.018")
00192029004739Upper 5-5 Cuspid With Hooks, 0.56 mm (.022")
00192029004708Upper 5-5 Cuspid With Hooks, 0.46 mm (.018")
00192029004609Lower Right Cuspid -6 Torque, +3 Tip, 0.56 mm (.022") Without Vertical Slot, Bondable
00192029004586Lower Left Cuspid -6 Torque, +3 Tip, 0.56 mm (.022") Without Vertical Slot, Bondable
00192029004562Lower Right Cuspid -6 Torque, +3 Tip Without Vertical Slot, Bondable 0.46mm (.018")
00192029004548Lower Left Cuspid -6 Torque, +3 Tip, 0.46 mm (.018") Without Vertical Slot, Bondable
00192029004524Lower Left/Right Anteriors -6 Torque, 0 Tip, 0.56 mm (.022") Without Vertical Slot, B
00192029004487Lower Left/Right Anteriors -6 Torque, 0 Tip, 0.46 mm (.018") Without Vertical Slot, Bo
00192029004449Upper Right Cuspid -7 Torque, +8 Tip, 0.56 mm (.022") Without Vertical Slot, Bondable
00192029004425Upper Left Cuspid -7 Torque, +8 Tip, 0.56 mm (.022") Without Vertical Slot, Bondable
00192029004401Upper Right Cuspid -7 Torque, +8 Tip, 0.46 mm (.018") Without Vertical Slot, Bondable
00192029004388Upper Left Cuspid -7 Torque, +8 Tip, 0.46 mm (.018") Without Vertical Slot, Bondable
00192029004364Upper Right Lateral +10 Torque, +8 Tip, 0.56 mm (.022") Without Vertical Slot, B
00192029004326Upper Left Lateral +10 Torque, +8 Tip, 0.56 mm (.022") Without Vertical Slot, B
00192029004289Upper Right Lateral +10 Torque, +8 Tip, 0.46 mm (.018") Without Vertical Slot, Bo
00192029004241Upper Left Lateral +10 Torque, +8 Tip, 0.46 mm (.018") Without Vertical Slot, Bo
00192029004203Upper Right Central +17 Torque, +4 Tip, 0.56 mm (.022") Without Vertical Slot, Bo
00192029004166Upper Left Central +17 Torque, +4 Tip, 0.56 mm (.022") Without Vertical Slot, Bo
00192029004128Upper Right Central +17 Torque, +4 Tip, 0.46 mm .018") Without Vertical Slot, B
00192029004081Upper Left Central +17 Torque, +4 Tip, 0.46 mm (.018") Without Vertical Slot, Bo
00192029004043Upper & Lower 5-5 Without Hooks, 0.56 mm (.022")
00192029004029Upper & Lower 5-5 Cuspid With Hooks, 0.56 mm (.022")
00192029003992Upper & Lower 5-5 Cuspid With Hooks, 0.46 mm (.018")
00192029003978Upper & Lower 3-3 Without Hooks, 0.56 mm (.022")
00192029003947Lower Right 1st Bicuspid With Hook -12 Torque, 0 Tip Without Vertical Slot, Bondable 0.56mm (.02

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