(342 days)
No
The description explicitly states the use of "standard dental software" and does not mention any AI or ML capabilities. The process described is based on clinician input and standard design software, not adaptive or learning algorithms.
Yes
The device is used to treat tooth malocclusions by gradually repositioning teeth, which is a therapeutic purpose.
No
The device is a treatment system that gradually realigns teeth using physical force, rather than diagnosing a condition. Its function is to move teeth into alignment, not to identify or characterize a disease or condition.
No
The device description explicitly states that the system consists of "a custom-made series of plastic aligners" which are physical, thermoplastic devices. While software is used in the design process, the final medical device delivered to the patient is a physical product.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The TP Orthodontics Clear Aligner System is a physical device (plastic aligners) used to mechanically move teeth. It does not perform any diagnostic testing on biological samples.
- Intended Use: The intended use is for the "treatment of tooth malocclusions," which is a therapeutic purpose, not a diagnostic one.
- Device Description: The description details the physical nature of the aligners and their application to the teeth.
- Anatomical Site: The anatomical site is "Teeth," which are part of the body but the device interacts with them externally to apply force, not to analyze biological samples from them.
The device is a medical device used for treatment, not for diagnosis.
N/A
Intended Use / Indications for Use
TP Orthodontics Clear Aligner System consists of a series of plastic appliances indicated for the treatment of tooth malocclusions in patients with permanent dentition (i.e. all second molars). Utilizing a series of incremental tooth movements, TP Orthodontics Clear Aligner System sequentially positions teeth by way of continuous gentle force.
Product codes
NXC
Device Description
TP Orthodontics Clear Aligner System consists of a custom-made series of plastic aligners that apply gentle pressure to teeth, gradually moving them into alignment.
A dentist or orthodontist assesses the patient to determine if the patient is a good candidate. Impressions are taken by the dental clinician and submitted to TP Orthodontics along with the physician's prescription.
TP Orthodontics, using a standard dental software used for teeth alignment, designs a series of plastic aligners intended to gradually realign the patient's teeth in accordance to the doctor's prescription. The set-up and intermediate stages are sent back to the physician for review and approval. Once the doctor has approved the model scheme, the aligners are produced using a thermoplastic material and shipped to the dental practitioner.
The doctor delivers the aligners to the patient in sequential stages, provides instructions for use (such as when to change aligners), and monitors the case progression and fit and function from the first aligner through the end of treatment through follow-up appointments.
Aligners must be worn by the patient most of the day (20-22h), being removed only for eating, drinking and performing oral hygiene and should be replaced every 2-3 weeks as prescribed by the doctor.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
patients with permanent dentition (i.e. all second molars)
Intended User / Care Setting
Dentist or orthodontist / Dental clinician
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Clinical Performance Data: The clinical performance of sequential aligners (product code NXC) has been well established since the first device of this category was cleared by the FDA in 1998. TP Orthodontics Clear Aligner System have equivalent indication and method of use to its primary and reference predicate devices, therefore there was no clinical testing to support this device.
Non-Clinical Performance Data: A manufacturing validation was performed to ensure the dimensional accuracy of TP Orthodontics Clear Aligner System and assess the integration between the steps of the manufacturing process. The validation demonstrated that the aligners manufactured match the software output specifications. Physical properties testing was obtained from the clearance for the Aligner Material from Dentsply, 510(k) K062828.
Biocompatibility Testing: Biocompatibility tests were not performed as TP Orthodontics Clear Aligner System are made of the same material (thermoplastic material) as its primary and reference predicate devices. The material used (Aligner Material from Dentsply, 510(k) K062828) is the same used in the fabrication of MTM aligners (reference predicate device), and therefore there are no differences in biocompatibility between them. Biocompatibility testing data was obtained from the clearance for the Aligner Material from Dentsply, 510(k) K062828.
Software Verification and Validation Testing: Both software used with TP Orthodontics Clear Aligner System passed their validations.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.5470 Orthodontic plastic bracket.
(a)
Identification. An orthodontic plastic bracket is a plastic device intended to be bonded to a tooth to apply pressure to a tooth from a flexible orthodontic wire to alter its position.(b)
Classification. Class II.
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November 12, 2020
TP Orthodontics Inc. Stephanie Thyen QA/RA Manager 100 Center Plaza La Porte, Indiana 46350-9672
Re: K193385
Trade/Device Name: TP Orthodontics Clear Aligner System Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: Class II Product Code: NXC Dated: September 24, 2020 Received: October 5, 2020
Dear Stephanie Thyen:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for Srinivas "Nandu" Nandkumar, Ph.D. Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K193385
Device Name
TP Orthodontics Clear Aligner System
Indications for Use (Describe)
TP Orthodontics Clear Aligner System consists of a series of plastic appliances indicated for the treatment of tooth malocclusions in patients with permanent dentition (i.e. all second molars). Utilizing a series of incremental tooth movements, TP Orthodontics Clear Aligner System sequentially positions teeth by way of continuous gentle force.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ---------------------------------------------- | --------------------------------------------- |
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Image /page/3/Picture/0 description: The image shows the logo for TP Orthodontics, Inc. The logo consists of a blue globe with an arrow wrapping around it on the left side. To the right of the globe is the text "TP Orthodontics, Inc." in a simple, sans-serif font.
K193385
November 20, 2019
510(k) Summary
Submitter Information:
TP Orthodontics, Inc. 100 Center Plaza, La Porte, IN Contact Person: Cristiane Muller Phone Number: 1.800.348.8856 / 219.785.2591 Fax: 219.324.3029 E-mail: cristiane.muller@tportho.com
Device Information:
Trade Name: TP Orthodontics Clear Aligner System Common Name: Aligners, Sequential Product Code: NXC Classification Name: Orthodontic Plastic Bracket Regulation Number: 872-5470 Device Class: II Classification Panel: Dental
Predicate Devices:
| Device | Applicant | 510(k) Number |
|---|---|---|
| 3M Clear Tray Aligner | 3M Unitek Corporation | K163689 |
Reference Predicate Devices:
| Device | Applicant | 510(k) Number |
|---|---|---|
| Ortho System | 3Shape A/S | K180941 |
| Mouthguard and Aligner | ||
| Material | Dentsply International | K062828 |
| MTM Clear Aligner | Dentsply Sirona | K163155 |
Indications for Use:
TP Orthodontics Clear Aligner System consists of a series of plastic appliances indicated for the treatment of tooth malocclusions in patients with permanent dentition (i.e. all second molars). Utilizing a series of incremental tooth movements, TP Orthodontics Clear Aligner System sequentially positions teeth by way of continuous gentle force.
Device Description and Summary of Technological Characteristics:
TP Orthodontics Clear Aligner System consists of a custom-made series of plastic aligners that apply gentle pressure to teeth, gradually moving them into alignment.
A dentist or orthodontist assesses the patient to determine if the patient is a good candidate. Impressions are taken by the dental clinician and submitted to TP Orthodontics along with the physician's prescription.
TP Orthodontics, using a standard dental software used for teeth alignment, designs a series of plastic aligners intended to gradually realign the patient's teeth in accordance to the doctor's prescription. The set-up and intermediate stages are sent back to the physician for review and approval. Once the doctor
4
has approved the model scheme, the aligners are produced using a thermoplastic material and shipped to the dental practitioner.
The doctor delivers the aligners to the patient in sequential stages, provides instructions for use (such as when to change aligners), and monitors the case progression and fit and function from the first aligner through the end of treatment through follow-up appointments.
Aligners must be worn by the patient most of the day (20-22h), being removed only for eating, drinking and performing oral hygiene and should be replaced every 2-3 weeks as prescribed by the doctor.
| Characteristic | TP Orthodontics
Clear Aligner
System
Proposed Device | 3M Clear Tray
Aligner
Primary Predicate | MTM Clear Aligner
Reference
Predicate | Comparison |
|---------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) | To be determined | K163689 | K163155 | N/A |
| Manufacturer | TP Orthodontics,
Inc. | 3M Unitek
Corporation | Dentsply Sirona/
Raintree Essix Inc. | N/A |
| Regulation Number | 21 CFR 872.5470 | 21 CFR 872.5470 | 21 CFR 872.5470 | Same |
| Device | Orthodontic Plastic
Bracket | Orthodontic Plastic
Bracket | Orthodontic Plastic
Bracket | Same |
| Classification Name | Orthodontic Plastic
Bracket | NXC | NXC | Same |
| Product Code | NXC | NXC | NXC | Same |
| Device Class | Class II | Class II | Class II | Same |
| Indications for Use | TP Orthodontics
Clear Aligner
System consists of a
series of plastic
appliances indicated
for the treatment of
tooth malocclusions
in patients with
permanent dentition
(i.e. all second
molars). Utilizing a
series of
incremental tooth
movements, TP
Orthodontics Clear
Aligner System
sequentially
positions teeth by
way of continuous
gentle force. | The 3M Clear Tray
Aligner System is a
series of clear,
lightweight, plastic
appliances indicated
for the treatment of
tooth malocclusions
in patients with
permanent dentition
(i.e. all second
molars). Utilizing a
series of incremental
tooth movements, it
sequentially positions
teeth by way of
continuous gentle
force. | MTM® Clear Aligner
is indicated for the
treatment of anterior
tooth malocclusions
in patients with
permanent dentition
(i.e. all second
molars). Utilizing a
series of
incremental minor
tooth movements,
MTM® Clear Aligner
sequentially
positions teeth by
way of continuous
gentle force. | Similar. The
verbiage of the
indications for use
is slightly different
than the primary
and reference
predicates,
however, these
slight differences in
wording do not
change the
intended use of the
subject device in
relation to the
predicate devices
and does not raise
any new questions
about safety and
effectiveness. |
| Intended Population | Individuals with
permanent dentition | Individuals with
permanent dentition | Individuals with
permanent dentition | Same |
| Material | Co-polyester or co-
polymer;
Thermoplastic | Thermoplastic | Co-polyester or co-
polymer;
Thermoplastic | Similar. All devices
are made of a
biocompatible
thermoplastic
material. |
| Mode of action | Continuous gentle
forces applied to
teeth to attain
orthodontic tooth
movement | Continuous gentle
forces applied to
teeth to attain
orthodontic tooth
movement | Continuous gentle
forces applied to
teeth to attain
orthodontic tooth
movement | Same |
| Characteristic | TP Orthodontics
Clear Aligner
System
Proposed Device | 3M Clear Tray
Aligner
Primary Predicate | MTM Clear Aligner
Reference
Predicate | Comparison |
| Method of Use | Aligners are worn by
the patient
according to the
treating doctor
prescription. | Aligners are worn by
the patient according
to the treating doctor
prescription. | Aligners are worn by
the patient
according to the
treating doctor
prescription. | Same |
| Software Used for
Ordering Workflow | Yes | Yes | Yes | Same |
| Prescription (Rx) or
Over-the-Counter
(OTC) | Rx | Rx | Rx | Same |
| Design of Aligners | Image: Clear aligner | Image: Clear aligner | Image: Clear aligner | Same. All are
comprised of clear
thermoplastic trays
that seat over the
teeth. |
Table 5.1. Substantial Equivalence Comparison
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Image /page/5/Picture/0 description: The image shows the logo for TP Orthodontics, Inc. The logo consists of a stylized globe with blue lines and an arrow wrapping around it. To the right of the globe is the text "TP Orthodontics, Inc.", with "TP" in a slightly larger font size than the rest of the text.
Clinical Performance Data
The clinical performance of sequential aligners (product code NXC) has been well established since the first device of this category was cleared by the FDA in 1998. TP Orthodontics Clear Aligner System have equivalent indication and method of use to its primary and reference predicate devices, therefore there was no clinical testing to support this device.
Non-Clinical Performance Data
A manufacturing validation was performed to ensure the dimensional accuracy of TP Orthodontics Clear Aligner System and assess the integration between the steps of the manufacturing process. The validation demonstrated that the aligners manufactured match the software output specifications. Physical properties testing was obtained from the clearance for the Aligner Material from Dentsply, 510(k) K062828.
Biocompatibility Testing
Biocompatibility tests were not performed as TP Orthodontics Clear Aligner System are made of the same material (thermoplastic material) as its primary and reference predicate devices. The material used (Aligner Material from Dentsply, 510(k) K062828) is the same used in the fabrication of MTM aligners (reference predicate device), and therefore there are no differences in biocompatibility between them. Biocompatibility testing data was obtained from the clearance for the Aligner Material from Dentsply, 510(k) K062828.
Software Verification and Validation Testing
Both software used with TP Orthodontics Clear Aligner System passed their validations.
Substantial Equivalence Conclusion
TP Orthodontics Clear Aligner System presents substantially equivalent indication for use and technological characteristics as its primary and reference predicate devices. There are slight differences in the language of the indications for use, however these differences do not impact safety and efficacy of the device.
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Image /page/6/Picture/0 description: The image shows the logo for TP Orthodontics, Inc. The logo consists of a blue globe with an arrow wrapping around it. The text "TP Orthodontics, Inc." is written in a simple, sans-serif font to the right of the globe. The logo is clean and professional, and the blue color gives it a sense of trustworthiness.
It is concluded that TP Orthodontics Clear Aligner System is safe, effective, and substantially equivalent to its primary and reference predicate devices.