MXi Tip-Edge Brackets

GUDID 00192029006580

.022" UPPER RIGHT LATERAL +8 TORQUE, +9 TIP, 4 MM WITH VERTICAL SLOT

TP ORTHODONTICS INC

Orthodontic bracket, ceramic
Primary Device ID00192029006580
NIH Device Record Key10da8885-8b4f-4c61-b0e5-c347ed8653de
Commercial Distribution StatusIn Commercial Distribution
Brand NameMXi Tip-Edge Brackets
Version Model Number298-821F
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
GS100192029006580 [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 Tip-Edge Brackets]

00192029006818.022" LOWER RIGHT CUSPID -11 TORQUE, +5 TIP, 5 MM WITH VERTICAL SLOT
00192029006801.022" LOWER LEFT CUSPID -11 TORQUE, +5 TIP, 5 MM WITH VERTICAL SLOT
00192029006795.022" UPPER LEFT CUSPID -2 TORQUE, +11 TIP, 5 MM WITH VERTICAL SLOT
00192029006788.022" LOWER CW BICUSPID -20 TORQUE, 0 TIP, 4.5 MM WITH VERTICAL SLOT
00192029006771.022" LOWER CCW BICUSPID -20 TORQUE, 0 TIP, 4.5 MM WITH VERTICAL SLOT
00192029006764.022" LOWER RIGHT CUSPID -11 TORQUE, +5 TIP, 4.5 MM WITH VERTICAL SLOT
00192029006757.022" LOWER LEFT CUSPID -11 TORQUE, +5 TIP, 4.5 MM WITH VERTICAL SLOT
00192029006740.022" UPPER CW BICUSPID -7 TORQUE, 0 TIP, 4.5 MM WITH VERTICAL SLOT
00192029006733.022" UPPER CCW BICUSPID -7 TORQUE, 0 TIP, 4.5 MM WITH VERTICAL SLOT
00192029006726.022" UPPER RIGHT CUSPID -2 TORQUE, +11 TIP, 4.5 MM WITH VERTICAL SLOT
00192029006719.022" UPPER LEFT CUSPID -2 TORQUE, +11 TIP, 4.5 MM WITH VERTICAL SLOT
00192029006702.022" UPPER RIGHT CENTRAL +12 TORQUE, +5 TIP, 4.5 MM WITH VERTICAL SLO
00192029006696.022" UPPER LEFT CENTRAL +12 TORQUE, +5 TIP, 4.5 MM WITH VERTICAL SLOT
00192029006689.022" LOWER CW BICUSPID -20 TORQUE, 0 TIP, 4 MM WITH VERTICAL SLOT
00192029006672.022" LOWER CCW BICUSPID -20 TORQUE, 0 TIP, 4 MM WITH VERTICAL SLOT
00192029006665.022" LOWER RIGHT CUSPID -11 TORQUE, +5 TIP, 4 MM WITH VERTICAL SLOT
00192029006658.022" LOWER LEFT CUSPID -11 TORQUE, +5 TIP, 4 MM WITH VERTICAL SLOT
00192029006641.022" LOWER RIGHT ANTERIOR -1 TORQUE, 0 TIP, 4 MM WITH VERTICAL SLOT
00192029006634.022" LOWER LEFT ANTERIOR -1 TORQUE, 0 TIP, 4 MM WITH VERTICAL SLOT
00192029006627.022" UPPER CW BICUSPID -7 TORQUE, 0 TIP, 4 MM WITH VERTICAL SLOT
00192029006610.022" UPPER CCW BICUSPID -7 TORQUE, 0 TIP, 4 MM WITH VERTICAL SLOT
00192029006603.022" UPPER RIGHT CUSPID -2 TORQUE, +11 TIP, 4 MM WITH VERTICAL SLOT
00192029006597.022" UPPER LEFT CUSPID -2 TORQUE, +11 TIP, 4 MM WITH VERTICAL SLOT
00192029006580.022" UPPER RIGHT LATERAL +8 TORQUE, +9 TIP, 4 MM WITH VERTICAL SLOT
00192029006573.022" UPPER LEFT LATERAL +8 TORQUE, +9 TIP, 4 MM WITH VERTICAL SLOT
00192029006566.022" UPPER RIGHT CENTRAL +12 TORQUE, +5 TIP, 4 MM WITH VERTICAL SLOT
00192029006559Upper Left Central with Vertical Slot +12 Torque, +5 Tip Oriented, 4 mm, Red 0.56 mm (.022")
00192029006542.022" LOWER CW BICUSPID -20 TORQUE, 0 TIP, 3.5 MM WITH VERTICAL SLOT
00192029006535.022" LOWER CCW BICUSPID -20 TORQUE, 0 TIP, 3.5 MM WITH VERTICAL SLOT
00192029006528.022" LOWER RIGHT ANTERIOR -1 TORQUE, 0 TIP, 3.5 MM WITH VERTICAL SLOT
00192029006511.022" LOWER LEFT ANTERIOR -1 TORQUE, 0 TIP, 3.5 MM WITH VERTICAL SLOT
00192029006504.022" UPPER RIGHT LATERAL +8 TORQUE, +9 TIP, 3.5 MM WITH VERTICAL SLOT
00192029006498.022" UPPER LEFT LATERAL +8 TORQUE, +9 TIP, 3.5 MM WITH VERTICAL SLOT
00192029006481LOWER 5-5 NON-EXTRACTION KIT .022" WIRE SLOT, WITH JIGS WITH VERTICAL SLOT
00192029006474LOWER 3-3 KIT .022" WIRE SLOT, WITH JIGS WITH VERTICAL SLOT
00192029006467UPPER & LOWER 5-5 NON-EXTRACTION KIT .022" SLOT, WITH JIGS, WITH VERTICAL SLOT
00192029006450UPPER & LOWER 3-3 KIT .022" WIRE SLOT, WITH JIGS WITH VERTICAL SLOT
00192029006443UPPER 5-5 NON-EXTRACTION KIT .022" WIRE SLOT, WITH JIGS WITH VERTICAL SLOT
00192029006436UPPER 3-3 KIT .022" WIRE SLOT, WITH JIGS WITH VERTICAL SLOT

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