Tp Orthodontics, Inc.
Active in EUDAMEDUnited Statesfrom SRN EUDAMED FDA SRN US-MF-000020559 FEI 1815540
- Devices
- 3,492
- Registrations
- EUDAMEDFDA
- FDA recalls
- 13
At a glance
Market reach
- European Union
- EUDAMED actor
- United States
- FDA FEI, FDA recalls
- Authorised rep.
- Advena LimitedMT
What Tp Orthodontics, Inc. makes
TP Orthodontics, Inc. manufactures orthodontic devices including metal and ceramic brackets, orthodontic wires, inter-bracket elastic chains, retainers, tubes, inter-arch elastic bands, and archwire/bracket ligatures. Their specific products include ClearVu Mini Ceramic Brackets, Straight Edge Metal Bracket, Begg Lingual Tube, Advant-Edge I Metal Bracket, Pre-Finisher Introductory Kit, Dispense-A-Tie Ligatures, InVu Ceramic Brackets, InVu Readi-Base Brackets, ORANGE Tru-Force Latex Elastics, TipEdge PLUS Ceramic Readi-Base Bracket, and TiMolium Titanium Wire.
The company's portfolio includes Class I and Class II devices, which are listed in the FDA Unique Device Identifier (UDI) registry. TP Orthodontics, Inc. is based in the United States.
Catalogue
Search and filter all 3,492 devicesShowing 1-50 of 3,492
Company details
- EUDAMED SRN
- US-MF-000020559
- FDA FEI number
- 1815540
- EUDAMED status
- Active
- EUDAMED registered name
- TP Orthodontics, Inc.
- EUDAMED abbreviated name
- TP Ortho
- Registered address
- 100, Center Plaza, 46350, La Porte, United States
- Website
- www.tportho.com/
- [email protected]
- PRRC contact
- Cristiane Muller
FDA recalls
FDA recall records list 13 recalls initiated by TP ORTHODONTICS, INC., initiated on 2018-05-01. By recorded status: 13 terminated. The reasons filed fall into these groups: mechanical integrity. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
Recalls initiated per year
- 2017 0
- 2018 13
- 2019 0
- 2020 0
- 2021 0
- 2022 0
- 2023 0
- 2024 0
- 2025 0
- 2026 0
2018
- 1 May 2018 Z-1783-2018 Class II Terminated The firm has received 106 complaints of the device breaking in the patient's mouth. Device breakage may cause injury to the patient.
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- 1 May 2018 Z-1784-2018 Class II Terminated The firm has received 106 complaints of the device breaking in the patient's mouth. Device breakage may cause injury to the patient.
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- 1 May 2018 Z-1785-2018 Class II Terminated The firm has received 106 complaints of the device breaking in the patient's mouth. Device breakage may cause injury to the patient.
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- 1 May 2018 Z-1786-2018 Class II Terminated The firm has received 106 complaints of the device breaking in the patient's mouth. Device breakage may cause injury to the patient.
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- 1 May 2018 Z-1787-2018 Class II Terminated The firm has received 106 complaints of the device breaking in the patient's mouth. Device breakage may cause injury to the patient.
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- 1 May 2018 Z-1788-2018 Class II Terminated The firm has received 106 complaints of the device breaking in the patient's mouth. Device breakage may cause injury to the patient.
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- 1 May 2018 Z-1789-2018 Class II Terminated The firm has received 106 complaints of the device breaking in the patient's mouth. Device breakage may cause injury to the patient.
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- 1 May 2018 Z-1790-2018 Class II Terminated The firm has received 106 complaints of the device breaking in the patient's mouth. Device breakage may cause injury to the patient.
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- 1 May 2018 Z-1791-2018 Class II Terminated The firm has received 106 complaints of the device breaking in the patient's mouth. Device breakage may cause injury to the patient.
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- 1 May 2018 Z-1792-2018 Class II Terminated The firm has received 106 complaints of the device breaking in the patient's mouth. Device breakage may cause injury to the patient.
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- 1 May 2018 Z-1783-2018 Class II Terminated The firm has received 106 complaints of the device breaking in the patient's mouth. Device breakage may cause injury to the patient.
Show all 13 recalls
2018
- 1 May 2018 Z-1793-2018 Class II Terminated The firm has received 106 complaints of the device breaking in the patient's mouth. Device breakage may cause injury to the patient.
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- 1 May 2018 Z-1794-2018 Class II Terminated The firm has received 106 complaints of the device breaking in the patient's mouth. Device breakage may cause injury to the patient.
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- 1 May 2018 Z-1795-2018 Class II Terminated The firm has received 106 complaints of the device breaking in the patient's mouth. Device breakage may cause injury to the patient.
Full distribution text
- 1 May 2018 Z-1793-2018 Class II Terminated The firm has received 106 complaints of the device breaking in the patient's mouth. Device breakage may cause injury to the patient.
Frequently asked questions
How many devices does TP ORTHODONTICS, INC. have in the registry?
The registry currently lists 3492 devices for TP ORTHODONTICS, INC.. Devices recorded under merged duplicate company entries are counted once.
Which registries list TP ORTHODONTICS, INC.'s devices?
Among its 50 most recently registered devices, TP ORTHODONTICS, INC. has devices listed in FDA GUDID (50 devices).
What risk classes do TP ORTHODONTICS, INC.'s devices fall under?
Among its 50 most recently registered devices, the classes recorded for TP ORTHODONTICS, INC.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for TP ORTHODONTICS, INC.?
FDA recall records list 13 recalls initiated by TP ORTHODONTICS, INC., the most recent initiated on 1 May 2018. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from TP ORTHODONTICS, INC. in the registry?
The most recently registered devices listed for TP ORTHODONTICS, INC. include ClearVu Mini Ceramic Brackets 297-292CV, Straight Edge Metal Bracket 292-180, Begg Lingual Tube 210-395L and Advant-Edge I Metal Bracket 294-174.