Manufacturer registered with FDA
Tp Orthodontics, Inc.
La Porte, IN, United States. Lists 26 dental device types with FDA across 2 registered establishments, and holds 5 510(k) clearances as applicant.
- Device types listed
- 26
- Brands and models
- 128
- 510(k) clearances
- 51995–2022
- Markets registered in
- 11378 registrations outside the US
- Establishments
- 2China, United States
510(k) clearances per year, 1990–2026
Registered in 11 markets
Where regulators' registries name Tp Orthodontics, Inc. as the manufacturer or the registration holder of a device.
RegisteredHome: United StatesOne marker per market
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Tp Orthodontics, Inc. | 5 clearances | 1995–2022 | Below |
| Canada | Health Canada | Registration holder | TP ORTHODONTICS INC | 276 | 2007–2026 | Pure Global AI |
| Australia | TGA | Manufacturer | TP Orthodontics Inc | 24 | 2005–2022 | Pure Global AI |
| Colombia | INVIMA | Registration holder | TP ORTHODONTICS INC. | 24 | — | Pure Global AI |
| Brazil | ANVISA | Manufacturer | TP ORTHODONTICS INCTP ORTHODONTICS INC. | 19 | 2004–2024 | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | TP Orthodontics, Inc. | 19 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | T.P.Orthodontics, IncT.P. Orthodontics Inc. · T.P. Orthodontics, Inc. · +2 | 10 | 2004–2012 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | TP Orthodontics, Inc. | 2 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | TP ORTHODONTICS, INC. | 2 | 2005–2016 | Pure Global AI |
| China | NMPA | Registration holder | 托博正畸有限公司TP Orthodontics, Inc. | 1 | — | Pure Global AI |
| Israel | AMAR | Manufacturer | TP Orthodontics, Inc | 1 | — | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What Tp Orthodontics, Inc. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Orthodontic Ceramic BracketNJM · Class 2 | Orthodontic brackets | Maker | ClearVuClearVu with pre-applied adhesiveClick-It Self Ligating BracketInVuInVu with pre-applied adhesiveMXIPlus CeramicTip Edge PLUS with pre-applied adhesive | 2008 |
| Resin Bracket and Tooth Conditioner AdhesiveDYH · Class 2 | — | Maker | Enamel Conditioner | 2008 |
| Orthodontic WireDZC · Class 1 | Orthodontic wires & bands | Maker | Aesthetic Nickel-Titanuim Preformed ArchwireAesthetic Stainless Steel Preformed ArchwireBio-Arch WiresBow-Flex ArchwireHeat Activated Nickel-Titanuim Preformed ArchwireLigature Wire on SpoolLip BumperLip Bumper CoatedLip Bumper with PadsLooped Preformed Archwire 10 moreMiscellaneous WiresMulti-Strand Preformed ArchwireNickel-Titanuim Preformed ArchwirePre-torqued Preformed ArchwirePreformed Ligature TiesStainless Steel Preformed ArchwireStainless Steel Straight ArchwireTiMolium Preformed ArchwireTP Original WireVELA Archwire System | 2006 |
| Orthodontic Elastic BandECI · Class 1 | Orthodontic wires & bands | Maker | Bump-R-Sleeve tubingE-ChainE-LinksElasticsElastomeric ligature tiesElastomeric SeperatorsElastomeric threadElastomeric tubingMini StixSep-A-Rings 5 moreSuper SlickTPO Elastic threadTPO Latex ElasticsTru-ForceZing String | 2006 |
| Orthodontic Preformed BandECM · Class 1 | Orthodontic wires & bands | Maker | Molar BandMolar Band AssembliesPRE-FIT PREFORMED BANDS | 2006 |
| Orthodontic Wire ClampECN · Class 1 | — | Maker | Aesthetic crimpable hookAesthetic crimpable stopBi level PinCRIMPABLE HOOKCRIMPABLE STOPSELASTIC OUTRIGGERLingual Button attachmentsLingual Cleat attachmentsLingual Hook attachmentsMXI CERAMIC POWER PINS 6 morePower hooksPower PinRETAINING RINGSRUMELY TRACTION HOOKSEPARATION MAINTAINERSTRACT HK W/LIGATING CHAIN | 2006 |
| Orthodontic Ligature Tucking InstrumentECP · Class 1 | Dental hand instruments | Maker | Straight shooter Ligature Applicator | 2014 |
| Polishing Agent StripEHM · Class 1 | Polishing & prophylaxis | Maker | MESIO-DISTAL REDUCER | 2006 |
| Orthodontic Metal BracketEJF · Class 1 | Orthodontic brackets | Maker | Begg Metal BracketGenerations BracketsNu-Edge II Cobalt Chromium Twin bracketNu-Edge NXNu-Edge SL Metal BracketNu-Edge SL Pre-coated Metal bracketNu-Edge, Straight Edge, Tip Edge, Advant- Edge, Twin-Edge BracketTip-Edge Plus MetalTip-Edge Plus NXTip-Edge Rx-I 1 more256 Begg Bracket | 2006 |
| Preformed Tooth PositionerKMY · Class 1 | Retainers, expanders & headgear | Maker | Custom retainerCustom tooth positionerPre-FinisherPre-finisher appliance with seating spring | 2008 |
| Orthodontic Screw Expansion RetainerDYJ · Class 1 | Retainers, expanders & headgear | Maker | Accufit retainerBaurmash bondable Arch BarBondable Lingual RetainerFlip-Lock Herbst ApplianceHawley RetainerLabial Trauma splintLingual Bond-a-Splint RetainerPerio Bond-a-Bar | 2020 |
| Orthodontic TubeDZD · Class 1 | Orthodontic wires & bands | Maker | Bondable Molar tubesBUCCAL TUBESCast Begg Molar TubesCast Tip-Edge Molar TubesCobalt Chromium TubesMisc. Tubes & AttachmentsSeamless Begg TubesSeamless Standard TubeSeamless Tip-Edge TubesWeldable Molar tubes | 2006 |
| Dental Hand InstrumentsDZN · Class 1 | Dental hand instruments | Maker | Bite StickOrthodontic instrumentsSwivel Key | 2021 |
| Resin Impression Tray MaterialEBH · Class 1 | Impression trays | Maker | — | 2019 |
| Orthodontic SpringECO · Class 1 | Orthodontic wires & bands | Maker | COIL SPRINGSLock PinsLock Pins OrientedORTHODONTIC SPRINGSROTATING SPRINGSSEPARATING SPRINGSSPRING PINSTorquing auxiliariesTwin Tip-Edge Aux.UPRIGHTING SPRINGS 1 moreVektorPRO Appliance-Spring | 2006 |
| Orthodontic Bracket AlignerECQ · Class 1 | Dental hand instruments | Maker | EDGEWISE BRACKETS256 BRACKETS | 2006 |
| Intraoral Dental WaxEGD · Class 1 | — | Lister | WAFERSWAX STRIPS | 2006 |
| Preformed Impression TrayEHY · Class 1 | Impression trays | Maker | Extend-O Iimpression TraysNorm-O Impression TraysSolay Disposable impression Trays | 2006 |
| Restorative and Impression Material SyringeEID · Class 1 | Dental hand instruments | Lister | Disposable Dispensing Tips | 2021 |
| Dental Retractor AccessoriesEIF · Class 1 | Dental hand instruments | Maker | Bonding accessories | 2006 |
| All Types RetractorEIG · Class 1 | Dental hand instruments | Maker | Lip and Cheek Retractor | 2021 |
| Dental BurEJL · Class 1 | Dental burs & diamonds | Maker | Debonding burs | 2021 |
| Orthodontic PlierJEX · Class 1 | Dental hand instruments | Maker | ORTHODONTIC PLIERS | 2006 |
| Resin Tooth Bonding AgentKLE · Class 2 | Bonding agents | Maker | — | 2022 |
| Resin ApplicatorKXR · Class 1 | — | Lister | Disposable brushesDisposable SpatulasFoam Pellets | 2021 |
| Sequential AlignerNXC · Class 2 | Clear aligners | Maker | Refine | 2021 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names Tp Orthodontics, Inc. as the applicant, including filings under its other names.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 14 Oct 2022 | K214054 | TP Orthodontics Light-Cure Adhesive System, TP Orthodontics Pre-Applied Adhesive, TP Orthodontics Etchant208520 | DYH Resin Bracket and Tooth Conditioner Adhesive |
| 12 Nov 2020 | K193385 | TP Orthodontics Clear Aligner System | NXC Sequential Aligner |
| 13 May 2011 | K111234 | CLICK-IT | NJM Orthodontic Ceramic Bracket |
| 11 Jul 1995 | K952643 | RIGHT-ON ADHESIVE BOUDING SYSTEM | DYH Resin Bracket and Tooth Conditioner Adhesive |
| 3 May 1995 | K950992 | CERAMAFLEX BRACKET SYSTEM | NJM Orthodontic Ceramic Bracket |
Also lists devices cleared under other names
Tp Orthodontics, Inc. lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Tp Laboratories, Inc. (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 28 Jun 1978 | K780619 | PREFORMED TOOTH POSITIONER | Tp Laboratories, Inc. | KMY Preformed Tooth Positioner |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| TP ORTHODONTICS, INC.FDA reg. 1815540 | LA PORTE, IN, United States | Manufacturer, Repacker / relabeler |
| WUXI TP ORTHODONTICS MATERIAL CO., LTD.FDA reg. 3005537733 | WUXI Jiangsu, China | Manufacturer, Repacker / relabeler |
Other names on FDA records
Wuxi TP Orthodontics Material Co., Ltd.
Sources
FDA establishment registration & device listing (search FDA, owner/operator 1815540). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.