Nu-Edge Cobalt Chromium Brackets

GUDID 00192029046470

LL CUS NO HK VERTICAL SLOT Torque -11, Tip +6 .046mm (0.018")

TP ORTHODONTICS INC

Orthodontic bracket, metal
Primary Device ID00192029046470
NIH Device Record Keybe941ebf-b8b0-4265-96ec-b2c04b543cec
Commercial Distribution StatusIn Commercial Distribution
Brand NameNu-Edge Cobalt Chromium Brackets
Version Model Number293-7581
Company DUNS005432299
Company NameTP ORTHODONTICS INC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)348-8856
Emailnicholas.smith@tportho.com
Phone+1(800)348-8856
Emailnicholas.smith@tportho.com
Phone+1(800)348-8856
Emailnicholas.smith@tportho.com
Phone+1(800)348-8856
Emailnicholas.smith@tportho.com
Phone+1(800)348-8856
Emailnicholas.smith@tportho.com
Phone+1(800)348-8856
Emailnicholas.smith@tportho.com
Phone+1(800)348-8856
Emailnicholas.smith@tportho.com
Phone+1(800)348-8856
Emailnicholas.smith@tportho.com
Phone+1(800)348-8856
Emailnicholas.smith@tportho.com
Phone+1(800)348-8856
Emailnicholas.smith@tportho.com
Phone+1(800)348-8856
Emailnicholas.smith@tportho.com
Phone+1(800)348-8856
Emailnicholas.smith@tportho.com
Phone+1(800)348-8856
Emailnicholas.smith@tportho.com
Phone+1(800)348-8856
Emailnicholas.smith@tportho.com
Phone+1(800)348-8856
Emailnicholas.smith@tportho.com
Phone+1(800)348-8856
Emailnicholas.smith@tportho.com
Phone+1(800)348-8856
Emailnicholas.smith@tportho.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100192029046470 [Primary]

FDA Product Code

EJFBRACKET, METAL, ORTHODONTIC

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-11-21
Device Publish Date2024-11-13

On-Brand Devices [Nu-Edge Cobalt Chromium Brackets]

00192029047811LR 2BI HK NE II MBT 22OFF
00192029047804LL 2BI HK NE II MBT 22OFF
00192029047507UR LAT
00192029047491UL LAT
00192029047484UR LAT
00192029047477UL LAT
00192029047460UR CEN
00192029047453UL CEN
00192029047446UR CEN
00192029047439UL CEN
00192029047422LR 2nd BI W/DISTAL HK
00192029047415LL 2nd BI W/DISTAL HK
00192029047408LR 2nd BI W/DISTAL HK
00192029047392LL 2nd BI W/DISTAL HK
00192029047385LR 2nd BI NO HK
00192029047378LL 2nd BI NO HK
00192029047361LR 2nd BI NO HK
00192029047347LR 1st BI W/DISTAL HK
00192029047330LL 1st BI W/DISTAL HK
00192029047323LR 1st BI W/DISTAL HK
00192029047316LL 1st BI W/DISTAL HK
00192029047309LR 1st BI NO HK
00192029047286LR 1st BI NO HK
00192029047279LL 1st BI NO HK
00192029047262LR CUS W/DISTAL HK
00192029047255LL CUS W/DISTAL HK
00192029047248LR CUS W/DISTAL HK
00192029047231LL CUS W/DISTAL HK
00192029047187LO UNIV ANT
00192029047170LO UNIV ANT
00192029047163UR UNIV BI W/DISTAL HK
00192029047156UL UNIV BI W/DISTAL HK
00192029047149UR UNIV BI W/DISTAL HK
00192029047132UL UNIV BI W/DISTAL HK
00192029047125UP UNIV BI NO HK
00192029047118UP UNIV BI NO HK
00192029047101UR CUS W/DISTAL HK
00192029047095UL CUS W/DISTAL HK
00192029047088UR CUS W/DISTAL HK
00192029047071UL CUS W/DISTAL HK
00192029047057UL CUS NO HK
00192029047040UR CUS NO HK
00192029047033UL CUS NO HK
00192029047026UR LAT
00192029047019UL LAT
00192029047002UR LAT
00192029046999UL LAT
00192029046982UR CEN
00192029046975UL CEN
00192029046968UR CEN
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