InVu Ceramic Bracket

GUDID 00192029001837

Adhesive Coated LO L/R 1st B

TP ORTHODONTICS INC

Orthodontic bracket, ceramic Orthodontic bracket, ceramic Orthodontic bracket, ceramic Orthodontic bracket, ceramic Orthodontic bracket, ceramic Orthodontic bracket, ceramic Orthodontic bracket, ceramic Orthodontic bracket, ceramic Orthodontic bracket, ceramic Orthodontic bracket, ceramic Orthodontic bracket, ceramic Orthodontic bracket, ceramic Orthodontic bracket, ceramic Orthodontic bracket, ceramic Orthodontic bracket, ceramic Orthodontic bracket, ceramic
Primary Device ID00192029001837
NIH Device Record Key164865f8-2a3c-4945-bd88-b821820d08b4
Commercial Distribution StatusIn Commercial Distribution
Brand NameInVu Ceramic Bracket
Version Model Number297-182RBX
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
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
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
Phone+1(219)785-2591
Emailnicholas.smith@tportho.com
Phone+1(219)785-2591
Emailnicholas.smith@tportho.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100192029001837 [Primary]

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 Date2022-02-09
Device Publish Date2022-02-01

On-Brand Devices [InVu Ceramic Bracket]

00192029013120UP 4-4 CUS W/HOOK
00192029001837Adhesive Coated LO L/R 1st B

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