Nu-Edge Bracket

GUDID 00192029046067

UL LAT

TP ORTHODONTICS INC

Orthodontic bracket, metal
Primary Device ID00192029046067
NIH Device Record Key3226f939-a0ac-4a79-b68e-f573142382df
Commercial Distribution StatusIn Commercial Distribution
Brand NameNu-Edge Bracket
Version Model Number293-1641
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 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

Customer Support Contacts

Phone+1(219)785-2591
Emailmatt.oswald@tportho.com
Phone+1(219)785-2591
Emailmatt.oswald@tportho.com
Phone+1(219)785-2591
Emailmatt.oswald@tportho.com
Phone+1(219)785-2591
Emailmatt.oswald@tportho.com
Phone+1(219)785-2591
Emailmatt.oswald@tportho.com
Phone+1(219)785-2591
Emailmatt.oswald@tportho.com
Phone+1(219)785-2591
Emailmatt.oswald@tportho.com
Phone+1(219)785-2591
Emailmatt.oswald@tportho.com
Phone+1(219)785-2591
Emailmatt.oswald@tportho.com
Phone+1(219)785-2591
Emailmatt.oswald@tportho.com
Phone+1(219)785-2591
Emailmatt.oswald@tportho.com
Phone+1(219)785-2591
Emailmatt.oswald@tportho.com
Phone+1(219)785-2591
Emailmatt.oswald@tportho.com
Phone+1(219)785-2591
Emailmatt.oswald@tportho.com
Phone+1(219)785-2591
Emailmatt.oswald@tportho.com
Phone+1(219)785-2591
Emailmatt.oswald@tportho.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100192029046067 [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 Date2022-02-09
Device Publish Date2022-02-01

On-Brand Devices [Nu-Edge Bracket]

00192029046760LO UNIV 1st BI NO HK VERTICAL SLOT
00192029046647LR 2nd BI W/DISTAL HK VERTICAL SLOT
00192029046630LL 2nd BI W/DISTAL HK VERTICAL SLOT
00192029046586LR 1st BI W/DISTAL HK VERTICAL SLOT
00192029046579LL 1st BI W/DISTAL HK VERTICAL SLOT
00192029046562LO UNIV 1st BI NO HK VERTICAL SLOT
00192029046517LL CUS W/DISTAL HK VERTICAL SLOT
00192029046487LR CUS NO HK VERTICAL SLOT
00192029046425UR BI W/MESIAL HK VERTICAL SLOT
00192029046364UR CUS W/DISTAL HK VERTICAL SLOT
00192029046326UR CUS NO HK VERTICAL SLOT
00192029046227LO UNIV BI NO HK
00192029046173UP UNIV BI W 188 BASE NO HK
00192029046128UP UNIV CEN
00192029046081UL LAT
00192029046074UR LAT
00192029046067UL LAT
00192029046050UR CEN
00192029046043UL CEN
00192029045992LR 2nd BI W/HK
00192029045985LL 2nd BI W/HK
00192029045978LR 1st BI W/HK
00192029045954LR 1st BI W/HK
00192029045947LL 1st BI W/HK
00192029045930LO UNIV 2nd BI NO HK
00192029045916LO UNIV 1st BI NO HK
00192029023969LO UNIV 2nd BI NO HK VERTICAL SLOT
00192029023952LO UNIV 1st BI NO HK VERTICAL SLOT
00192029023945LR 2nd BI W/DISTAL HK VERTICAL SLOT
00192029023938LL 2nd BI W/DISTAL HK VERTICAL SLOT
00192029023921LR 1st BI W/DISTAL HK VERTICAL SLOT
00192029023914LL 1st BI W/DISTAL HK VERTICAL SLOT
00192029023891LR 1st BI W/DISTAL HK VERTICAL SLOT
00192029023884LL 1st BI W/DISTAL HK VERTICAL SLOT
00192029023860LL CUS NO HK VERTICAL SLOT
00192029023846UL CUS NO HK VERTICAL SLOT
00192029023839UL BI W/HK
00192029023822UP UNIV BI W 188 BASE NO HK
00192029023808LR 2nd BI W/HK
00192029023792LL 2nd BI W/HK
00192029023778LL 1st BI W/HK
00192029015599LO UNIV 1st BI NO HK VERTICAL SLOT
00192029015582LR CUS W/DISTAL HK VERTICAL SLOT
00192029015575LL CUS W/DISTAL HK VERTICAL SLOT
00192029015568UR CUS W/DISTAL HK VERTICAL SLOT
00192029015551UL CUS W/DISTAL HK VERTICAL SLOT
00192029010419UR LAT VERTICAL SLOT
00192029010402UL LAT VERTICAL SLOT
00192029010396LO UNIV 1st BI NO HK VERTICAL SLOT
00192029010358LR CUS NO HK

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