Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1815540

FEI Number

1815540

Entity Name

TP ORTHODONTICS, INC.

City/State/Country

LA PORTE, IN, US

Establishment Address

100 CENTER PLAZA, LA PORTE, IN 46350, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

TP ORTHODONTICS, INC. (Owner Number: 1815540)

Owner / Operator Contact Address

100 CENTER PLAZA, --, La Porte, IN 46350, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Bite Stick Orthodontic instruments Swivel Key Heat Activated Nickel-Titanuim Preformed Archwire TP Original Wire Aesthetic Nickel-Titanuim Preformed Archwire Multi-Strand Preformed Archwire Nickel-Titanuim Preformed Archwire Pre-torqued Preformed Archwire Looped Preformed Archwire Stainless Steel Preformed Archwire Lip Bumper TiMolium Preformed Archwire Bio-Arch Wires Aesthetic Stainless Steel Preformed Archwire Ligature Wire on Spool Preformed Ligature Ties Lip Bumper Coated Lip Bumper with Pads Stainless Steel Straight Archwire VELA Archwire System Bow-Flex Archwire Miscellaneous Wires Pre-Finisher Pre-finisher appliance with seating spring Custom tooth positioner Custom retainer Disposable Dispensing Tips Norm-O Impression Trays Solay Disposable impression Trays Extend-O Iimpression Trays Tip-Edge Plus NX Tip-Edge Rx-I Begg Metal Bracket Nu-Edge, Straight Edge, Tip Edge, Advant- Edge, Twin-Edge Bracket 256 Begg Bracket Nu-Edge NX Nu-Edge SL Pre-coated Metal bracket Nu-Edge SL Metal Bracket Tip-Edge Plus Metal Nu-Edge II Cobalt Chromium Twin bracket Refine ROTATING SPRINGS VektorPRO Appliance-Spring SPRING PINS COIL SPRINGS SEPARATING SPRINGS Torquing auxiliaries Lock Pins Oriented UPRIGHTING SPRINGS ORTHODONTIC SPRINGS Lock Pins Twin Tip-Edge Aux. EDGEWISE BRACKETS 256 BRACKETS PRE-FIT PREFORMED BANDS Molar Band Assemblies Molar Band Straight shooter Ligature Applicator Elastomeric Seperators Tru-Force Bump-R-Sleeve tubing Zing String E-Chain Sep-A-Rings Super Slick Elastomeric Ligature ties Elastomeric tubing Mini Stix TPO Elastic thread E-Links Elastomeric thread TPO Latex Elastics Elastomeric ligature ties Elastics WAX STRIPS WAFERS ORTHODONTIC PLIERS Enamel Conditioner Click-It Self Ligating Bracket SEPARATION MAINTAINERS CRIMPABLE HOOK Lingual Hook attachments Lingual Button attachments Lingual Cleat attachments RETAINING RINGS Bi level Pin MXI CERAMIC POWER PINS Power Pin CRIMPABLE STOPS RUMELY TRACTION HOOK Aesthetic crimpable stop ELASTIC OUTRIGGER Power hooks Aesthetic crimpable hook TRACT HK W/LIGATING CHAIN

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DZN	Instruments, Dental Hand	Dental	Class 1	872.4565	2021-03-04
DZC	Wire, Orthodontic	Dental	Class 1	872.5410	2006-01-06
KMY	Positioner, Tooth, Preformed	Dental	Class 1	872.5525	2008-12-08
EID	Syringe, Restorative And Impression Material	Dental	Class 1	872.4565	2021-11-17
EHY	Tray, Impression, Preformed	Dental	Class 1	872.6880	2006-01-06
EJF	Bracket, Metal, Orthodontic	Dental	Class 1	872.5410	2006-01-06
NXC	Aligner, Sequential	Dental	Class 2	872.5470	2021-11-17
ECO	Spring, Orthodontic	Dental	Class 1	872.5410	2006-01-06
ECQ	Aligner, Bracket, Orthodontic	Dental	Class 1	872.4565	2006-01-06
ECM	Band, Preformed, Orthodontic	Dental	Class 1	872.5410	2006-01-06
ECP	Instrument, Ligature Tucking, Orthodontic	Dental	Class 1	872.4565	2014-04-28
ECI	Band, Elastic, Orthodontic	Dental	Class 1	872.5410	2006-01-06
EGD	Wax, Dental, Intraoral	Dental	Class 1	872.6890	2006-01-06
KLE	Agent, Tooth Bonding, Resin	Dental	Class 2	872.3200	2022-12-05
DYH	Adhesive, Bracket And Tooth Conditioner, Resin	Dental	Class 2	872.3750	2022-12-05
JEX	Plier, Orthodontic	Dental	Class 1	872.4565	2006-01-06
DYH	Adhesive, Bracket And Tooth Conditioner, Resin	Dental	Class 2	872.3750	2008-12-16
NJM	Bracket, Ceramic, Orthodontic	Dental	Class 2	872.5470	2011-12-14
ECN	Clamp, Wire, Orthodontic	Dental	Class 1	872.5410	2006-01-06

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

TP ORTHODONTICS, INC.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3005537733	WUXI TP ORTHODONTICS MATERIAL CO., LTD.	WUXI Jiangsu, CN

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K112640	Ormco Corp.	HYPERELASTIC WIRE	2011-11-16
K894358	Ormco Corp.	LUMINA ORTHODONTIC BRACKET	1989-09-15
K925012	American Orthodontics	PLASTIC CHAIN	1993-09-13
K020499	Jeneric/Pentron, Inc.	BOND-3 ADHESIVE	2002-04-22
K801093	Dentsply Intl.	PRISMA-BOND	1980-05-20

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0012-2012	Biomet Microfixation, Inc.	1	Biomet Microfixation outer packaging labeled in part:"REF: SP-2411*RUBBER BAND, LATEX FREE SMALL, HEAVY, 300/PACKAGE 4MM, (3/16" INNER DIAMETER) NON LATEX ELASTICS LOT 307850DISTRIBUTED BY: BIOMET MICROFIXATION 1520 Tradeport Drive, Jacksonville, FL 32218 USA www.biometmicrofixation.com." Inner Vendor/Manufacturer Label labeled in part:"H4 Elastics 4mm (3/16") Heavy 4 oz. REF 11-102-04Manufactured for DENTSPLY GAC INTERNATIONAL DENTSPLY INTERNATIONAL, INC. Phone 631-419-1700 Fax 631-419-1599 355 Knickerbocker Avenue Bohemia NY 11716 USAMediMark Europe BP2332 F-38033 Grenoble Cedex 2. FranceLOT 82936-32 QTY:100 pk use by 2012-07 Made in USA ISSUED DATE 2009-04 GN**" Elastic bands used as elastomeric ties for ligation that facilitate treatment of fracture of the mandible and maxilla. They are commonly used with braces or arch bar wire.
Z-0035-2008	Heraeus Kulzer Inc., Dental Products Division	2	Heraeus Kulzer GLUMA Comfort Bond + Desensitizer light curing one component adhesive, contents: 4 ml, dental bonding agent. Distributed by Heraeus Kulzer, Inc., Armonk, NY; Reorder No. 66001710.
Z-0036-2008	Heraeus Kulzer Inc., Dental Products Division	2	Heraeus Kulzer GLUMA Comfort Bond + Desensitizer light curing one component adhesive, Assortment Value Pack 3 x 4 ml, dental bonding agent. Distributed by Heraeus Kulzer, Inc., Armonk, NY; Reorder No. 66018222.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1815540. Last updated year: 2026. Please use registration number 1815540 when referencing this establishment in official correspondence.