MXi Straight-Edge Bracket

GUDID 00192029006320

Upper Left Lateral with Vertical Slot +8 Torque, +9 Tip Oriented, 4 mm, Red 0.56 mm (.022")

TP ORTHODONTICS INC

Orthodontic bracket, ceramic
Primary Device ID00192029006320
NIH Device Record Keyefb32688-b8ce-4134-b749-29e78e77a401
Commercial Distribution StatusIn Commercial Distribution
Brand NameMXi Straight-Edge Bracket
Version Model Number298-526F
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
GS100192029006320 [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 [MXi Straight-Edge Bracket]

00192029006429.022" LOWER LEFT/RIGHT UNIVERSAL BICUSPID -20 TORQUE, 0 TIP, 4.5 MM WITH VERTICAL SLOT
00192029006412.022" UPPER LEFT/RIGHT UNIVERSAL BICUSPID -7 TORQUE, 0 TIP, 4.5 MM WITH VERTICAL SLOT
00192029006405.022" UPPER RIGHT CUSPID -2 TORQUE, +11 TIP, 4.5 MM WITH VERTICAL SLOT
00192029006399.022" UPPER LEFT CUSPID -2 TORQUE, +11 TIP, 4.5 MM WITH VERTICAL SLOT
00192029006382.022" UPPER RIGHT CENTRAL +12 TORQUE, +5 TIP, 4.5 MM WITH VERTICAL SLOT
00192029006375.022" UPPER LEFT CENTRAL +12 TORQUE, +5 TIP, 4.5 MM WITH VERTICAL SLOT
00192029006368.022" LOWER RIGHT CUSPID -11 TORQUE, +5 TIP, 4 MM WITH VERTICAL SLOT
00192029006351.022" LOWER LEFT CUSPID -11 TORQUE, +5 TIP, 4 MM WITH VERTICAL SLOT
00192029006344.022" LOWER LEFT/RIGHT UNIVERSAL ANTERIOR -1 TORQUE, 0 TIP, 4 MM WITH VERTICAL SLOT
00192029006337.022" UPPER RIGHT LATERAL +8 TORQUE, +9 TIP, 4 MM WITH VERTICAL SLOT
00192029006320Upper Left Lateral with Vertical Slot +8 Torque, +9 Tip Oriented, 4 mm, Red 0.56 mm (.022")
00192029006313CUSPIDS BRACKETS KIT .022" ROTH RX WITH LONGER JIGS

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