ClearVu Mini Readi-Base Brackets

GUDID 00192029001257

Upper Right Lateral +7 Torque, +8 Tip 0.46 mm (.018"), Bondable

TP ORTHODONTICS INC

Orthodontic bracket, ceramic

• Primary Device ID: 00192029001257
• NIH Device Record Key: 064dc811-da1e-402f-82c2-c270b8ceba93
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ClearVu Mini Readi-Base Brackets
• Version Model Number: 297-149CVX
• 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	00192029001257 [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: 2019-02-15

On-Brand Devices [ClearVu Mini Readi-Base Brackets]

• 00192029005668: Bi-Dimensional Brackets with Hooks 0.46 mm (.018") centrals and laterals with 0.56 mm (.0
• 00192029005644: Bi-Dimensional Brackets with Hooks 0.46 mm (.018") centrals and laterals with 0.56 mm (.0
• 00192029005613: Lower Right Cuspid with Distal Hook 0 Torque, +3 Tip 0.56 mm (.022"), Bondable
• 00192029005576: Lower Left Cuspid with Distal Hook 0 Torque, +3 Tip 0.56 mm (.022"), Bondable
• 00192029005538: Lower Right Cuspid with Distal Hook 0 Torque, +3 Tip 0.46 mm (.018"), Bondable
• 00192029005491: Lower Left Cuspid with Distal Hook 0 Torque, +3 Tip 0.46 mm (.018"), Bondable
• 00192029005453: Lower Right Cuspid with Distal Hook -11 Torque, +6 Tip 0.56 mm (.022"), Bondable
• 00192029005415: Lower Left Cuspid with Distal Hook -11 Torque, +6 Tip 0.56 mm (.022"), Bondable
• 00192029005378: Lower Right Cuspid with Distal Hook -11 Torque, +6 Tip 0.46 mm (.018") Bondable
• 00192029005330: Lower Left Cuspid with Distal Hook -11 Torque, +6 Tip 0.46 mm (.018"), Bondable
• 00192029005293: Upper Right Cuspid with Distal Hook 0 Torque, +8 Tip, 0.56 mm (.022") Bondable
• 00192029005255: Upper Left Cuspid with Distal Hook 0 Torque, +8 Tip, 0.56 mm (.022") Bondable
• 00192029005217: Upper Right Cuspid with Distal Hook 0 Torque, +8 Tip, 0.46 mm (.018") Bondable
• 00192029005170: Upper Left Cuspid with Distal Hook 0 Torque, +8 Tip, 0.46 mm (.018") Bondable
• 00192029005132: Upper & Lower 5-5 Cuspid/Bicuspid with Hooks 0.56 mm (.022"), Bondable
• 00192029005095: Upper & Lower 5-5 Cuspid/Bicuspid with Hooks 0.46 mm (.018"), Bondable
• 00192029005057: Upper 5-5 Cuspid/Bicuspid with Hooks 0.56 mm (.022"), Bondable
• 00192029005019: Upper 5-5 Cuspid/Bicuspid with Hooks 0.46 mm (.018"), Bondable
• 00192029004975: Upper & Lower 5-5 Cuspid/Bicuspid with Hooks 0.56 mm (.022") Bondable
• 00192029004937: Upper & Lower 5-5 Cuspid/Bicuspid with Hooks 0.46 mm (.018") Bondable
• 00192029004890: Upper 5-5 Cuspid/Bicuspid with Hooks 0.56 mm (.022") Bondable
• 00192029004852: Upper 5-5 Cuspid/Bicuspid with Hooks 0.46 mm (.018") Bondable
• 00192029004647: Upper 3-3 Cuspid with Hooks 0.56 mm (.022"), Bondable
• 00192029004623: Upper 3-3 Cuspid with Hooks 0.46 mm (.018"), Bondable
• 00192029004517: Lower Universal Anteriors Narrow -6 Torque, 0 Tip 0.56 mm (.022"), Bondable
• 00192029004470: Lower Universal Anteriors Narrow -6 Torque, 0 Tip 0.46 mm (.018"), Bondable
• 00192029004357: Upper Right Lateral +10 Torque , +8 Tip 0.56 mm (.022"), Bondable
• 00192029004319: Upper Left Lateral +10 Torque , +8 Tip 0.56 mm (.022"), Bondable
• 00192029004272: Upper Right Lateral +10 Torque , +8 Tip 0.46 mm (.018"), Bondable
• 00192029004234: Upper Left Lateral +10 Torque , +8 Tip 0.46 mm (.018"), Bondable
• 00192029004197: Upper Right Central +17 Torque, +4 Tip 0.56 mm (.022"), Bondable
• 00192029004159: Upper Left Central +17 Torque, +4 Tip 0.56 mm (.022"), Bondable
• 00192029004111: Upper Right Central +17 Torque, +4 Tip 0.46 mm (.018"), Bondable
• 00192029004074: Upper Left Central +17 Torque, +4 Tip 0.46 mm (.018"), Bondable
• 00192029003916: Lower Right 1st Bicuspid with Hook -12 Torque, 0 Tip 0.56 mm (.022"), Bondable
• 00192029003855: Lower Left 1st Bicuspid with Hook -12 Torque, 0 Tip 0.56 mm (.022"), Bondable
• 00192029003794: Lower Right 1st Bicuspid with Hook -12 Torque, 0 Tip 0.46 mm (.018"), Bondable
• 00192029003732: Lower Left 1st Bicuspid with Hook Torque -12 , Tip 0 0.46 mm (.018"), Bondable
• 00192029003671: Lower Right 2nd Bicuspid with Hook -22 Torque, 0 Tip 0.56 mm (.022"), Bondable
• 00192029003619: Lower Left 2nd Bicuspid with Hook -22 Torque, 0 Tip 0.56 mm (.022"), Bondable
• 00192029003558: Lower Right 2nd Bicuspid with Hook -22 Torque, 0 Tip 0.46 mm (.018"), Bondable
• 00192029003497: Lower Left 2nd Bicuspid with Hook -22 Torque, 0 Tip 0.46 mm (.018"), Bondable
• 00192029003435: Lower Right 1st Bicuspid/Lower Right 2nd Bicuspid w/Hook -17 Torque, 0 Tip, 0.56 mm (.022") Bo
• 00192029003374: Lower Left 1st Bicuspid/Lower Left 2nd Bicuspid w/Hook Torque -17, Tip 0 , 0.56 mm (.022") B
• 00192029003312: Lower Right 1st Bicuspid/Lower Right 2nd Bicuspid w/Hook -17 Torque, 0 Tip, 0.46 mm (.018") Bo
• 00192029003251: Lower Left 1st Bicuspid/Lower Left 2nd Bicuspid w/Hook -17 Torque, 0 Tip, 0.46 mm (.018") Bo
• 00192029003190: Roth UR Unv. Bicuspid w / Hk; MBT UL Unv. Bicuspid w / Hk -7 Torque, 0 Tip, 0.56 mm (.022") Bo
• 00192029003138: Roth UL Unv. Bicuspid w / Hk; MBT UR Unv. Bicuspid w / Hk -7 Torque, 0 Tip, 0.56 mm (.022") Bo
• 00192029003077: Roth UR Unv. Bicuspid w / Hk; MBT UL Unv. Bicuspid w / Hk -7 Torque, 0 Tip, 0.46 mm (.018") Bo
• 00192029003015: Roth UL Unv. Bicuspid w / Hk; MBT UR Unv. Bicuspid w / Hk -7 Torque, 0 Tip, 0.46 mm (.018") Bo