TP Orthodontics, Inc.
La Porte, IN, US
TP ORTHODONTICS, INC. appears in FDA device records in La Porte, IN. FDA records list 5 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 13 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 5 510(k) clearances for TP Orthodontics, Inc. between 1995 and 2022. The busiest year on record is 1995, with 2. The most recent is 2022, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1995 | 2 |
| 2011 | 1 |
| 2020 | 1 |
| 2022 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K214054 | TP Orthodontics Light-Cure Adhesive System, TP Orthodontics Pre-Applied Adhesive, TP Orthodontics Etchant208520 | DYH | Substantially Equivalent | |
| K193385 | TP Orthodontics Clear Aligner System | NXC | Substantially Equivalent | |
| K111234 | CLICK-IT | NJM | Substantially Equivalent | |
| K952643 | RIGHT-ON ADHESIVE BOUDING SYSTEM | DYH | Substantially Equivalent | |
| K950992 | CERAMAFLEX BRACKET SYSTEM | NJM | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1815540 | 1815540 | TP ORTHODONTICS, INC. | 100 CENTER PLAZA, LA PORTE, IN 46350 US | 2026 | and 17 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- EIFAccessories, Retractor, Dental
- DYHAdhesive, Bracket And Tooth Conditioner, Resin
- KLEAgent, Tooth Bonding, Resin
- ECQAligner, Bracket, Orthodontic
- NXCAligner, Sequential
- KXRApplicator, Resin
- ECIBand, Elastic, Orthodontic
- ECMBand, Preformed, Orthodontic
- NJMBracket, Ceramic, Orthodontic
- EJFBracket, Metal, Orthodontic
- EJLBur, Dental
- ECNClamp, Wire, Orthodontic
- FMADepressor, Tongue, Non-Surgical
- ECPInstrument, Ligature Tucking, Orthodontic
- DZNInstruments, Dental Hand
- EBHMaterial, Impression Tray, Resin
- JEXPlier, Orthodontic
- KMYPositioner, Tooth, Preformed
- DYJRetainer, Screw Expansion, Orthodontic
- EIGRetractor, All Types
- ECOSpring, Orthodontic
- EHMStrip, Polishing Agent
- EIDSyringe, Restorative And Impression Material
- EHYTray, Impression, Preformed
- DZDTube, Orthodontic
- EGDWax, Dental, Intraoral
- DZCWire, Orthodontic
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1795-2018 | Jasper Vektor, Class II Correction Appliance, Part No. 610-536R 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. | Class II | Terminated | |
| Z-1794-2018 | Jasper Vektor, Class II Correction Appliance, Part No. 610-536L 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. | Class II | Terminated | |
| Z-1793-2018 | Jasper Vektor, Class II Correction Appliance, Part No. 610-533R 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. | Class II | Terminated | |
| Z-1792-2018 | Jasper Vektor, Class II Correction Appliance, Part No. 610-536 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. | Class II | Terminated | |
| Z-1791-2018 | Jasper Vektor, Class II Correction Appliance, Part No. 610-533Lused 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. | Class II | Terminated | |
| Z-1790-2018 | Jasper Vektor, Class II Correction Appliance, Part No. 610-530R 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. | Class II | Terminated | |
| Z-1789-2018 | Jasper Vektor, Class II Correction Appliance, Part No. 610-530L 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. | Class II | Terminated | |
| Z-1788-2018 | Jasper Vektor, Class II Correction Appliance, Part No. 610-527R 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. | Class II | Terminated | |
| Z-1787-2018 | Jasper Vektor, Class II Correction Appliance, Part No. 610-527L 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. | Class II | Terminated | |
| Z-1786-2018 | Jasper Vektor, Class II Correction Appliance, Part No. 610-533 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. | Class II | Terminated | |
| Z-1785-2018 | Jasper Vektor, Class II Correction Appliance, Part No. 610-530 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. | Class II | Terminated | |
| Z-1784-2018 | Jasper Vektor, Class II Correction Appliance, Part No. 610-527 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. | Class II | Terminated | |
| Z-1783-2018 | Jasper Vektor, Class II Correction Appliance, Part No. 610-500 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. | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain