TipEdge Plus Ceramic Brackets

GUDID 00192029005972

.022" LOWER BICUSPID - CCW 4.0 MM, PURPLE I.D. -20 TORQUE, 0 TIP

TP ORTHODONTICS INC

Orthodontic bracket, ceramic
Primary Device ID00192029005972
NIH Device Record Key75cf3f66-56a2-40e0-873f-ba320b4288bc
Commercial Distribution StatusIn Commercial Distribution
Brand NameTipEdge Plus Ceramic Brackets
Version Model Number297-653
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
GS100192029005972 [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 Date2019-02-13

On-Brand Devices [TipEdge Plus Ceramic Brackets]

00192029006122.022" LOWER RIGHT CUSPID 5.0 MM, BLACK I.D. -11 TORQUE, +5 TIP
00192029006115.022" LOWER LEFT CUSPID 5.0 MM, BLACK I.D. -11 TORQUE, +5 TIP
00192029006108.022" UPPER RIGHT CUSPID 5.0 MM, BLACK I.D. -2 TORQUE, +11 TIP
00192029006092.022" UPPER LEFT CUSPID 5.0 MM, BLACK I.D. -2 TORQUE, +11 TIP
00192029006085.022" LOWER BICUSPID - CW 4.5 MM, PURPLE I.D. -20 TORQUE, 0 TIP
00192029006078.022" LOWER BICUSPID - CCW 4.5 MM, PURPLE I.D. -20 TORQUE, 0 TIP
00192029006061.022" LOWER RIGHT CUSPID 4.5 MM, BLACK I.D. -11 TORQUE, +5 TIP
00192029006054.022" LOWER LEFT CUSPID 4.5 MM, BLACK I.D. -11 TORQUE, +5 TIP
00192029006047.022" UPPER BICUSPID - CW 4.5 MM, PURPLE I.D. -7 TORQUE, 0 TIP
00192029006030.022" UPPER BICUSPID - CCW 4.5 MM, PURPLE I.D. -7 TORQUE, 0 TIP
00192029006023.022" UPPER RIGHT CUSPID 4.5 MM, BLACK I.D. -2 TORQUE, +11 TIP
00192029006016.022" UPPER LEFT CUSPID 4.5 MM, BLACK I.D. -2 TORQUE, +11 TIP
00192029006009.022" UPPER RIGHT CENTRAL 4.5 MM, RED I.D. +12 TORQUE, +5 TIP
00192029005996.022" UPPER LEFT CENTRAL 4.5 MM, RED I.D. +12 TORQUE, +5 TIP
00192029005989.022" LOWER BICUSPID - CW 4.0 MM, PURPLE I.D. -20 TORQUE, 0 TIP
00192029005972.022" LOWER BICUSPID - CCW 4.0 MM, PURPLE I.D. -20 TORQUE, 0 TIP
00192029005965.022" LOWER RIGHT CUSPID 4.0 MM, BLACK I.D. -11 TORQUE, +5 TIP
00192029005958.022" LOWER LEFT CUSPID 4.0 MM, BLACK I.D. -11 TORQUE, +5 TIP
00192029005941.022" LOWER RIGHT ANTERIOR 4.0 MM, RED I.D. -1 TORQUE, 0 TIP
00192029005934.022" LOWER LEFT ANTERIOR 4.0 MM, RED I.D. -1 TORQUE, 0 TIP
00192029005927.022" UPPER BICUSPID - CW 4.0 MM, PURPLE I.D. -7 TORQUE, 0 TIP
00192029005910.022" UPPER BICUSPID - CCW 4.0 MM, PURPLE I.D. -7 TORQUE, 0 TIP
00192029005903.022" UPPER RIGHT CUSPID 4.0 MM, BLACK I.D. -2 TORQUE, +11 TIP
00192029005897.022" UPPER LEFT CUSPID 4.0 MM, BLACK I.D. -2 TORQUE, +11 TIP
00192029005880.022" UPPER RIGHT LATERAL 4.0 MM, GREEN I.D. +8 TORQUE, +9 TIP
00192029005873.022" UPPER LEFT LATERAL 4.0 MM, GREEN I.D. +8 TORQUE, +9 TIP
00192029005866.022" UPPER RIGHT CENTRAL 4.0 MM, RED I.D. +12 TORQUE, +5 TIP

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.