Data / Medical devices / United States / TP Orthodontics, Inc.

TP Orthodontics, Inc.: FDA-registered device maker in La Porte, IN, United States, 6 510(k) clearances

Name: TP Orthodontics, Inc. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

TP Orthodontics, Inc. is registered with the FDA (registration 1815540) in La Porte, IN, United States. It lists 27 device types. The FDA files 6 510(k) clearances under its listings, the newest dated October 14, 2022. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 1815540
Address: 100 Center Plaza, La Porte, IN, United States, 46350
Owner or operator: TP ORTHODONTICS, INC. (1815540)
Roles: Manufacturer, Repackager or relabeler
First device listed: January 6, 2006
Registered through: 2026
Brand names listed: 256 BRACKETS, 256 Begg Bracket, Accufit retainer, Aesthetic Nickel-Titanuim Preformed Archwire, Aesthetic Stainless Steel Preformed Archwire, Aesthetic crimpable hook, Aesthetic crimpable stop, BUCCAL TUBES and more

Devices it lists

Device	Product code	Class	Role	Source
Accessories, Retractor, Dental	EIF	1	Manufacturer	accessdata.fda.gov
Adhesive, Bracket And Tooth Conditioner, Resin	DYH	2	Manufacturer	accessdata.fda.gov
Agent, Tooth Bonding, Resin	KLE	2	Manufacturer	accessdata.fda.gov
Aligner, Bracket, Orthodontic	ECQ	1	Manufacturer	accessdata.fda.gov
Aligner, Sequential	NXC	2	Manufacturer	accessdata.fda.gov
Applicator, Resin	KXR	1	Repackager or relabeler	accessdata.fda.gov
Band, Elastic, Orthodontic	ECI	1	Manufacturer	accessdata.fda.gov
Band, Preformed, Orthodontic	ECM	1	Manufacturer	accessdata.fda.gov
Bracket, Ceramic, Orthodontic	NJM	2	Manufacturer	accessdata.fda.gov
Bracket, Metal, Orthodontic	EJF	1	Manufacturer	accessdata.fda.gov
Bur, Dental	EJL	1	Manufacturer	accessdata.fda.gov
Clamp, Wire, Orthodontic	ECN	1	Manufacturer	accessdata.fda.gov
Depressor, Tongue, Non-Surgical	FMA	1	Manufacturer	accessdata.fda.gov
Instrument, Ligature Tucking, Orthodontic	ECP	1	Manufacturer	accessdata.fda.gov
Instruments, Dental Hand	DZN	1	Manufacturer	accessdata.fda.gov
Material, Impression Tray, Resin	EBH	1	Manufacturer	accessdata.fda.gov
Plier, Orthodontic	JEX	1	Manufacturer	accessdata.fda.gov
Positioner, Tooth, Preformed	KMY	1	Manufacturer	accessdata.fda.gov
Retainer, Screw Expansion, Orthodontic	DYJ	1	Manufacturer	accessdata.fda.gov
Retractor, All Types	EIG	1	Manufacturer	accessdata.fda.gov
Spring, Orthodontic	ECO	1	Manufacturer	accessdata.fda.gov
Strip, Polishing Agent	EHM	1	Manufacturer	accessdata.fda.gov
Syringe, Restorative And Impression Material	EID	1	Repackager or relabeler	accessdata.fda.gov
Tray, Impression, Preformed	EHY	1	Manufacturer	accessdata.fda.gov
Tube, Orthodontic	DZD	1	Manufacturer	accessdata.fda.gov
Wax, Dental, Intraoral	EGD	1	Repackager or relabeler	accessdata.fda.gov
Wire, Orthodontic	DZC	1	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
October 14, 2022	K214054	TP Orthodontics Light-Cure Adhesive System, TP Orthodontics Pre-Applied Adhesive, TP Orthodontics Etchant208520	DYH	Substantially Equivalent	Tp Orthodontics, Inc.	accessdata.fda.gov
November 12, 2020	K193385	TP Orthodontics Clear Aligner System	NXC	Substantially Equivalent	Tp Orthodontics, Inc.	accessdata.fda.gov
May 13, 2011	K111234	CLICK-IT	NJM	Substantially Equivalent	Tp Orthodontics, Inc.	accessdata.fda.gov
July 11, 1995	K952643	RIGHT-ON ADHESIVE BOUDING SYSTEM	DYH	Substantially Equivalent	Tp Orthodontics, Inc.	accessdata.fda.gov
May 3, 1995	K950992	CERAMAFLEX BRACKET SYSTEM	NJM	Substantially Equivalent	Tp Orthodontics, Inc.	accessdata.fda.gov
June 28, 1978	K780619	PREFORMED TOOTH POSITIONER	KMY	Substantially Equivalent	Tp Laboratories, Inc.	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
May 1, 2018	79739	Class II	Terminated	Jasper Vektor, Class II Correction Appliance, Part No. used for correcting class 2 malocclusions by applying light forces on the teeth using a tube, arch wire and stops.	The firm has received 106 complaints of the device breaking in the patient's mouth. Device breakage may cause injury to the patient.	accessdata.fda.gov

Compare with other makers

Updated October 14, 2022. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.