(87 days)
Not Found
No
The summary describes software used for creating 3D models and treatment plans, but there is no mention of AI or ML being used in this process. The focus is on traditional software and manufacturing methods.
Yes
The device is indicated for the "treatment of tooth malocclusion" and "positions teeth by way of continuous gentle force," which describes a therapeutic action.
No
The device is an orthodontic system designed to correct tooth malocclusions, not to diagnose medical conditions. It uses physical impressions or digital scans to create a treatment plan and manufacture aligners, which falls under treatment, not diagnosis.
No
The device description clearly states that the system is comprised of "a series of clear, thin, thermoformed removable aligner trays," which are physical hardware components. While software (OrthoWare and OrthoPortal) is used in the design and manufacturing process, the final medical device delivered to the patient is a physical product.
Based on the provided information, the Ortho Aligner System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Ortho Aligner System Function: The Ortho Aligner System is a physical device (aligner trays) used to apply force to teeth to correct malocclusion. It directly interacts with the patient's teeth and mouth.
- Input: While it uses digital intraoral scans (which are images of the teeth), these scans are used to design and manufacture the physical aligners, not to analyze biological specimens.
- Purpose: The purpose is mechanical correction of tooth position, not diagnostic testing of biological samples.
The device description clearly outlines a process of creating customized physical aligners based on scans and a treatment plan, which is consistent with a medical device used for treatment, not an IVD used for diagnosis.
N/A
Intended Use / Indications for Use
The Ortho Aligner System is indicated for the treatment of tooth malocclusion in patients with permanent dentition (i.e. all second molars). The Ortho Aligner System positions teeth by way of continuous gentle force.
Product codes (comma separated list FDA assigned to the subject device)
NXC
Device Description
The Ortho Aligner System is comprised of a series of clear, thin, thermoformed removable aligner trays that are designed to correct tooth malocclusions without the use of conventional wire and bracket orthodontic technology. The aligners are provided non-sterile and are customized for each patient according to the dental practitioner's prescription.
Physical impressions or digital intraoral scans of the patient's teeth are provided to Ortho Lab Services. A treatment plan consisting of 3D models is created from the impressions or scans, by Ortho Lab Services using the OrthoWare software. Upon approval of the treatment plan by the treating dental practitioner using OrthoPortal and issuance of an electronic prescription, the clear aligners are manufactured using thermoforming methods.
The finished, customized aligners are shipped based on the dental practitioner's order and confirmed for patient fit and design.
The aligner trays are held in place by pressure and can be removed by the patient at any time.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Physical impressions or digital intraoral scans
Anatomical Site
tooth
Indicated Patient Age Range
patients with permanent dentition (i.e. all second molars)
Intended User / Care Setting
dental practitioner / Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Biocompatibility: Testing of the plastic thermoformable material was performed for the material supplier by a contract test laboratory according to Good Laboratory Practices and to meet the requirements of ISO 10993-1 and Part 5 (Cytotoxicity) and Part 10 (Sensitization). In addition to the material biocompatibility, the submitter contracted to have testing performed according to ISO 10993-5 (Cytotoxicity) of the finished thermoformed aligner. All biocompatibility testing passed the test requirements.
Software Verification and Validation Testing: Software V & V testing, using FDA's guidance document, confirmed acceptance to required specifications.
Bench testing: Testing to validate the manufacturing process was performed. The test results ensured the accuracy of the final thermoformed aligner compared to the initial digital scans. Aligners met the specifications of the testing.
In vivo Animal and Human Clinical: Animal and human performance testing are not required for this device category.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
0
Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services seal on the left and the FDA acronym followed by the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the agency name in a sans-serif font.
November 4, 2021
Ortho Lab Services, LLC % Patsy Trisler Regulatory Consultant Qserve Group US, Inc. 7949 Beaumont Green East Drive Indianapolis, Indiana 46250
Re: K212496
Trade/Device Name: Ortho Aligner System Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: Class II Product Code: NXC Dated: August 6, 2021 Received: August 9, 2021
Dear Patsy Trisler:
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 Michael E. Adjodha, M.ChE. Assistant Director DHT1B: Division of Dental and ENT 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) K212496
Device Name
Ortho Aligner System
Indications for Use (Describe)
The Ortho Aligner System is indicated for the treatment of tooth malocclusion in patients with permanent dentition (i.e. all second molars). The Ortho Aligner System 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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3
510(k) SUMMARY – K212496
| SUBMITTER | |
|---|---|
| Submitter Name: | Ortho Lab Services, LLC |
| Submitter Address: | 251 Little Falls |
| Wilmington, DE 19808 | |
| Contact Person: | |
| Telephone: | Zuzana Huelsbusch, Regulatory Director |
| 0049-1573-0655-886 | |
| Date Prepared: | October 28, 2021 |
| DEVICE | |
| Device Trade Name: | Ortho Aligner System |
| Common Name: | Aligner, Sequential (Clear Braces) |
| Classification Name | |
| Number | |
| Product Code | |
| Regulatory Class | Orthodontic Plastic Bracket |
| 21 CFR 872.5470 | |
| NXC | |
| 2 | |
| Review Panel | Dental |
| PREDICATE DEVICE | K172765, Smart Moves Complete, Great Lakes Orthodontics, |
| Ltd. | |
| INDICATIONS FOR | |
| USE STATEMENT | The Ortho Aligner System is indicated for the treatment of tooth |
| malocclusion in patients with permanent dentition (i.e. all | |
| second molars). The Ortho Aligner System positions teeth by | |
| way of continuous gentle force. | |
| DEVICE | |
| DESCRIPTION | The Ortho Aligner System is comprised of a series of clear, |
| thin, thermoformed removable aligner trays that are designed to | |
| correct tooth malocclusions without the use of conventional | |
| wire and bracket orthodontic technology. The aligners are | |
| provided non-sterile and are customized for each patient | |
| according to the dental practitioner's prescription. | |
| Physical impressions or digital intraoral scans of the patient's | |
| teeth are provided to Ortho Lab Services. A treatment plan | |
| consisting of 3D models is created from the impressions or | |
| scans, by Ortho Lab Services using the OrthoWare software. | |
| Upon approval of the treatment plan by the treating dental | |
| practitioner using OrthoPortal and issuance of an electronic | |
| prescription, the clear aligners are manufactured using | |
| thermoforming methods. | |
| The finished, customized aligners are shipped based on the | |
| dental practitioner's order and confirmed for patient fit and | |
| design. | |
| The aligner trays are held in place by pressure and can be | |
| removed by the patient at any time. | |
| MECHANISM OF | |
| ACTION | Each aligner in sequence applies the pressure (continuous |
| force) on the teeth targeted to be repositioned in that step. | |
| Once the prescribed treatment period is concluded, the next set | |
| of aligner trays is used; this continues until the realignment goal | |
| has been met. The patient wears the thermoformed aligners for | |
| the prescribed time in sequence, as monitored and guided by | |
| the clinical/dental practitioner. | |
| SUMMARY OF | |
| TECHNOLOGICAL | |
| CHARACTERISTICS | Materials |
| The thermoplastic materials used for the manufacture of the | |
| Ortho Aligners is the same material type which is used to make | |
| the Predicate Smart Moves Complete aligners, a PET-G | |
| thermoplastic sheet. |
Design
The subject aligners are designed using similar methods and
similar design software as the Predicate. Ortho Lab Services
uses their OrthoWare software, which is similar to the Predicate
manufacturer's Smart Moves Complete 3-D software.
Manufacturing Process
The process used to manufacture the Ortho Aligner System is
thermoforming the material on a model (or mold), the same
process method as used by the Predicate device manufacturer. |
| SAFETY TESTING | Biocompatibility: Testing of the plastic thermoformable material
was performed for the material supplier by a contract test
laboratory according to Good Laboratory Practices and to meet
the requirements of ISO 10993-1 and Part 5 (Cytotoxicity) and
Part 10 (Sensitization).
In addition to the material biocompatibility, the submitter
contracted to have testing performed according to ISO 10993-5
(Cytotoxicity) of the finished thermoformed aligner.
All biocompatibility testing passed the test requirements. |
| PERFORMANCE
TESTING | Software Verification and Validation Testing
Software V & V testing, using FDA's guidance document,
confirmed acceptance to required specifications.
Bench testing
Testing to validate the manufacturing process was performed.
The test results ensured the accuracy of the final thermoformed
aligner compared to the initial digital scans. Aligners met the
specifications of the testing.
In vivo Animal and Human Clinical
Animal and human performance testing are not required for this
device category. |
| COMPARISON TO
THE PREDICATE
DEVICE | The Ortho Aligner System has the same intended use as the predicate device. |
| | There are no fundamental technological differences between the subject and Predicate device. The differences, listed below, do not raise new types of safety and effectiveness questions:
• The materials are of the same type: biocompatible PET-G sheets, developed for use by dental device manufacturers for fabricating customized dental appliances, including aligners. |
| | • The software products used for design of the subject and Predicate devices are different, but have the same purpose and are used in a similar way to design the treatment plans for tooth movement. They both use digital scans to generate images of the final treated states, and intermediate steps to achieve the final state, and convert those files to produce the series of customized aligners. |
| | • The manufacturing process methods are different but similar: both use standard methods and equipment to thermoform the designed aligners. |
| CONCLUSION | The conclusions drawn from the side-by-side comparison and the nonclinical testing presented in the 510(k), demonstrate that the subject Ortho Aligner System is as safe and effective, and thus substantially equivalent to, the legally-marketed Smart Moves Complete Predicate. |
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5
6
Substantial Equivalence Comparison Table
| | Subject Device | Predicate Device
K172765 | Comparison |
|---------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------|
| Device Name | Ortho Aligner System | Smart Moves Complete | N/A |
| Manufacturer | Ortho Lab Services, LLC | Great Lakes Orthodontics Ltd | N/A |
| Classification
Regulation #
and Name
Product Code
Class | 21 CFR 872.5470
Orthodontic Plastic Bracket
NXC
2 | 21 CFR 872.5470
Orthodontic Plastic Bracket
NXC
2 | Same |
| Indications for
Use | The Ortho Aligner System is
indicated for the treatment of
tooth malocclusion in
patients with permanent
dentition (i.e. all second
molars). The Ortho Aligner
System positions teeth by
way of continuous gentle
force. | Smart Moves Complete is
indicated for the treatment of
tooth malocclusion in patients
with permanent dentition (i.e.
all second molars). Smart
Moves Complete positions
teeth by way of continuous
gentle force. | Same |
| Mode of Action | The appliance applies gentle
forces on teeth according to
the plan prescribed by the
doctor. | The appliance applies gentle
forces on teeth according to
the plan prescribed by the
doctor. | Same |
| Description of
Use | Each removable preformed
plastic tray is worn by the
patient as prescribed by the
doctor, usually a few weeks
prior to using the next
sequential aligner tray. | Each removable preformed
plastic tray is worn by the
patient as prescribed by the
doctor, usually a few weeks
prior to using the next
sequential aligner tray. | Same |
| Material | Thermoplastic PETG | Thermoplastic PETG | Same material type |
| Manufacturing
Process | Thermoforming on models | Thermoforming on models | Same process,
similar methods |
| Software Used | Yes, for treatment planning
and design of sequential
trays by Ortho Lab Services. | Yes, for treatment planning
and design of sequential
trays. | Same purposes;
Similar software |
| Prescription
Use | Rx | Rx | Same |
| Single Patient
Use | Yes | Yes | Same |
| Biocompatibility | Meets ISO 10993-1, -5, -10
requirements: Cytotoxicity
and Sensitization/Irritation | Meets ISO 10993-1, -5, -10
requirements: Cytotoxicity
and Sensitization/Irritation | Same |
| Process Flow
Validation
Testing | Performed testing to validate
the finished device matches
the software output design. | Performed testing to validate
the finished device matches
the software output design. | Same |