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 ID00192029001257
NIH Device Record Key064dc811-da1e-402f-82c2-c270b8ceba93
Commercial Distribution StatusIn Commercial Distribution
Brand NameClearVu Mini Readi-Base Brackets
Version Model Number297-149CVX
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
GS100192029001257 [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 Date2019-02-15

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

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

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