Ball-End Seating Springs

GUDID 00192029049624

Large

TP ORTHODONTICS INC

Orthodontic spring
Primary Device ID00192029049624
NIH Device Record Key57742765-940c-47c5-8289-edeb98e55ac1
Commercial Distribution StatusIn Commercial Distribution
Brand NameBall-End Seating Springs
Version Model Number400-601
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 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
Emailnicholas.smith@tportho.com
Phone+1(219)785-2591
Emailnicholas.smith@tportho.com
Phone+1(219)785-2591
Emailnicholas.smith@tportho.com
Phone+1(219)785-2591
Emailnicholas.smith@tportho.com
Phone+1(219)785-2591
Emailnicholas.smith@tportho.com
Phone+1(219)785-2591
Emailnicholas.smith@tportho.com
Phone+1(219)785-2591
Emailnicholas.smith@tportho.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100192029049624 [Primary]

FDA Product Code

ECOSPRING, ORTHODONTIC

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-05-17
Device Publish Date2022-05-09

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00192029050552 - Tip-Edge PLUS Stainless Steel Brackets2025-02-12 UL LAT Torque +8, Tip +9
00192029050569 - Tip-Edge PLUS Stainless Steel Brackets2025-02-12 UR LAT Torque +8, Tip +9
00192029050576 - Tip-Edge PLUS Stainless Steel Brackets2025-02-12 UL CUS Torque -4, Tip +11
00192029050583 - Tip-Edge PLUS Stainless Steel Brackets2025-02-12 UR CUS Torque -4, Tip +11
00192029050590 - Tip-Edge PLUS Stainless Steel Brackets2025-02-12 UP BI CCW Torque -7, Tip 0
00192029050606 - Tip-Edge PLUS Stainless Steel Brackets2025-02-12 UP BI CW Torque -7, Tip 0

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