First Molar Single Convertible Micro6

GUDID 00192029027318

UR 1st Molars Torque -10, Tip 0, Distal Offset 4 0.56 mm x 0.71 mm (.022" x .028") 4.0mm

TP ORTHODONTICS INC

Orthodontic tube
Primary Device ID00192029027318
NIH Device Record Key9a36c612-5fc6-4f00-9fc8-84ee2a6e839e
Commercial Distribution StatusIn Commercial Distribution
Brand NameFirst Molar Single Convertible Micro6
Version Model Number391-985
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
GS100192029027318 [Primary]

FDA Product Code

DZDTUBE, 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 [First Molar Single Convertible Micro6]

00192029027295UR 1st Molars Torque -10, Tip 0, Distal Offset 4
00192029027288UL 1st Molars Torque -10, Tip 0, Distal Offset 4
00192029027318UR 1st Molars Torque -10, Tip 0, Distal Offset 4 0.56 mm x 0.71 mm (.022" x .028") 4.0mm
00192029027301UL 1st Molars Torque -10, Tip 0, Distal Offset 4 0.56 mm x 0.71 mm (.022" x .028") 4.0mm

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