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 ID: 00192029003336
• NIH Device Record Key: b657fd19-630f-4a16-bf00-b1894d891a9a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: InVu Readi-Base Brackets
• Version Model Number: 297-289MRX
• Company DUNS: 005432299
• Company Name: TP ORTHODONTICS INC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00192029003336 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K950992

FDA Product Code

• NJM: Bracket, ceramic, orthodontic

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-03-11
• Device Publish Date: 2019-02-14

On-Brand Devices [InVu Readi-Base Brackets]

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