InVu Ceramic Brackets

GUDID 00192029002254

Upper Left Lateral +10 Torque, +8 Tip Without Vertical Slot, Bondable 0.46mm (.018")

TP ORTHODONTICS INC

Orthodontic bracket, ceramic
Primary Device ID00192029002254
NIH Device Record Key647e188b-1f41-4b33-bb12-4dd9cf642a87
Commercial Distribution StatusIn Commercial Distribution
Brand NameInVu Ceramic Brackets
Version Model Number297-214
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
GS100192029002254 [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 Date2019-02-20

On-Brand Devices [InVu Ceramic Brackets]

00192029006306INVU STANDARD UPPER/ LOWER 5-5 .022KIT OR
00192029006290INVU STANDARD UPPER/ LOWER 5-5 .018KIT OR
00192029006283INVU STANDARD UPPER 5-5 .022 KIT
00192029006276INVU STANDARD UPPER 5-5 .018 KIT
00192029006269INVU STANDARD UPPER 3-3 .022 KIT
00192029006252INVU STANDARD UPPER 3-3 .018 KIT
00192029006245.022" LOWER LEFT/RIGHT BICUSPID W/O HOOK 0 TORQUE, 0 TIP BONDABLE
00192029006238.018" LOWER LEFT/RIGHT BICUSPID W/O HOOK 0 TORQUE, 0 TIP BONDABLE
00192029006221.022" UPPER LEFT/RIGHT BICUSPID W/O HOOK 0 TORQUE, 0 TIP BONDABLE
00192029006214.018" UPPER LEFT/RIGHT BICUSPID W/O HOOK 0 TORQUE, 0 TIP BONDABLE
00192029006207.022" LOWER LEFT/RIGHT ANTERIORS 0 TORQUE, 0 TIP BONDABLE
00192029006191.018" LOWER LEFT/RIGHT ANTERIORS 0 TORQUE, 0 TIP BONDABLE
00192029006184.022" UPPER/LOWER & LEFT/RIGHT CUSPID 0 TORQUE, 0 TIP BONDABLE
00192029006177.018" UPPER/LOWER & LEFT/RIGHT CUSPID 0 TORQUE, 0 TIP BONDABLE
00192029006160.022" UPPER LEFT/RIGHT LATERAL 0 TORQUE, 0 TIP BONDABLE
00192029006153.018" UPPER LEFT/RIGHT LATERAL 0 TORQUE, 0 TIP BONDABLE
00192029006146.022" UPPER LEFT/RIGHT CENTRAL 0 TORQUE, 0 TIP BONDABLE
00192029006139.018" UPPER LEFT/RIGHT CENTRAL 0 TORQUE, 0 TIP BONDABLE
00192029005590Lower Right Cuspid With Hook 0 Torque, +3 Tip 0.56mm (.022")
00192029005552Lower Left Cuspid With Hook 0 Torque, +3 Tip 0.56mm (.022")
00192029005514Lower Right Cuspid With Hook 0 Torque, +3 Tip 0.46mm (.018")
00192029005477Lower Left Cuspid With Hook 0 Torque, +3 Tip 0.46mm (.018")
00192029005439Lower Right Cuspid With Hook -11 Torque, +6 Tip Without Vertical Slot, Bondable 0.56mm (.022")
00192029005392Lower Left Cuspid With Hook -11 Torque, +6 Tip Without Vertical Slot, Bondable 0.56mm (.022")
00192029005354Lower Right Cuspid With Hook -11 Torque, +6 Tip Without Vertical Slot, Bondable 0.46mm (.018")
00192029005316Lower Left Cuspid With Hook -11 Torque, +6 Tip Without Vertical Slot, Bondable 0.46mm (.018")
00192029005279Upper Right Cuspid With Hook 0 Torque, +8 Tip Without Vertical Slot 0.56mm (.022")
00192029005231Upper Left Cuspid With Hook 0 Torque, +8 Tip Without Vertical Slot 0.56mm (.022")
00192029005194Upper Right Cuspid With Hook 0 Torque, +8 Tip Without Vertical Slot 0.46mm (.018")
00192029005156Upper Left Cuspid With Hook 0 Torque, +8 Tip Without Vertical Slot 0.46mm (.018")
00192029005118Upper & Lower 5-5 With Cuspid/Bicuspid Hooks 0.56mm (.022")
00192029005071Upper & Lower 5-5 With Cuspid/Bicuspid Hooks 0.46mm (.018")
00192029005033Upper 5-5 With Cuspid/Bicuspid Hooks 0.56mm (.022")
00192029004999Upper 5-5 With Cuspid/Bicuspid Hooks 0.46mm (.018")
00192029004951Upper & Lower 5-5 Cuspid/Bicuspid With Hooks 0.56mm (.022")
00192029004913Upper & Lower 5-5 Cuspid/Bicuspid With Hooks 0.46mm (.018")
00192029004876Upper 5-5 Cuspid/Bicuspid With Hooks 0.56mm (.022")
00192029004838Upper 5-5 Cuspid/Bicuspid With Hooks 0.46mm (.018")
00192029004814Cuspid/Bicuspid With Hooks Upper & Lower 5-5 0.56mm (.022")
00192029004791Cuspid/Bicuspid With Hooks Upper & Lower 5-5 0.46mm (.018")
00192029004777Cuspid/Bicuspid With Hooks Upper 5-5 0.56mm (.022")
00192029004753Cuspid/Bicuspid With Hooks Upper 5-5 0.46mm (.018")
00192029004746Upper 5-5 Without Hooks 0.56mm (.022")
00192029004722Upper 5-5 Without Hooks 0.56mm (.022")
00192029004715Upper 5-5 Without Hooks 0.46mm (.018")
00192029004692Upper 5-5 With Cuspid Hooks 0.46mm (.018")
00192029004685Upper 3-3 Without Hooks 0.56mm (.022")
00192029004678Upper 3-3 Without Hooks 0.46mm (.018")
00192029004593Lower Right Cuspid Wo/Hook -6 Torque, +3 Tip 0.56mm (.022")
00192029004579Lower Left Cuspid Wo/Hook -6 Torque, +3 Tip 0.56mm (.022")

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