InVu Readi-Base Bracket

GUDID 00192029000533

Upper & Lower 5-5 Cuspid With Hooks 0.46mm (.018")

TP ORTHODONTICS INC

Orthodontic bracket, ceramic
Primary Device ID00192029000533
NIH Device Record Key57f48713-78c7-4fc6-b3d8-72175ba8ea87
Commercial Distribution StatusIn Commercial Distribution
Brand NameInVu Readi-Base Bracket
Version Model Number297-070RBX
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
GS100192029000533 [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 Date2019-02-22

On-Brand Devices [InVu Readi-Base Bracket]

00192029001622Lower Left/Right Anteriors -1 Torque, 0 Tip, 0.56 mm (.022") Without Vertical Slot, Bondabl
00192029000557Upper 5-5 Cuspid With Hooks 0.56mm (.022")
00192029000533Upper & Lower 5-5 Cuspid With Hooks 0.46mm (.018")
00192029000519Upper 5-5 Cuspid With Hooks 0.56mm (.022")
00192029000496Upper 5-5 Cuspid With Hooks 0.46mm (.018")

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