(198 days)
No
The description of the device and the software used (3Shape Ortho System) focuses on standard dental software functionalities for 3D model management, diagnosis, virtual planning, and design, without mentioning any AI or ML capabilities. The "Mentions AI, DNN, or ML" section is also marked as "Not Found".
Yes.
The device is indicated for the treatment of tooth malocclusions and applies continuous gentle force to position teeth, which directly addresses a medical condition.
No
The device description indicates that the 3Shape Ortho System software (a reference device) is used for "orthodontic diagnosis by measuring, analyzing, inspecting and visualizing 3D scanned orthodontic models". However, the Inman Digital Clear Aligners themselves are described as a "series of dental-clinician prescribed customized clear plastic removable orthodontic aligner trays" used for treatment, not diagnosis. The aligners are designed based on an evaluation and prescription by a clinician.
No
The device description clearly states that the device consists of "a series of dental-clinician prescribed customized clear plastic removable orthodontic aligner trays" which are physical, thermoformed plastic components. While software is used in the design process, the final medical device delivered to the patient is a physical object.
Based on the provided information, the Inman Digital Clear Aligners are not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Inman Digital Clear Aligners' Function: The Inman Digital Clear Aligners are physical devices that are placed in the patient's mouth to physically move teeth. They are a form of orthodontic appliance.
- 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 materials and manufacturing process of the physical aligner trays.
- Input: The input is intraoral scans or physical impressions of the teeth, which are used to create the physical device, not for laboratory analysis of biological specimens.
The device is a therapeutic orthodontic appliance, not a diagnostic tool that analyzes biological samples.
N/A
Intended Use / Indications for Use
Inman Digital Clear Aligners are indicated for the treatment of tooth malocclusions in patients with permanent dentition (i.e. all second molars). The Inman Digital Clear Aligners position teeth by way of continuous gentle force.
Product codes
NXC
Device Description
The Inman Digital Clear Aligners consist of a series of dental-clinician prescribed customized clear plastic removable orthodontic aligner trays that are made from a clear, thin thermoformed polyurethane.
A dental clinician prescribes the aligners based on an evaluation of the patient's teeth. Either intraoral scans or physical impressions of the patient's teeth are provided to Inman Orthodontic Lab by the dental clinician, along with the prescription. The series of plastic aligner trays are designed according to the prescription using standard dental software for planning the tooth alignments.
The software used is 3Shape Ortho System (Reference device K152086). It is used for managing 3D scanned orthodontic models, orthodontic diagnosis by measuring, analyzing, inspecting and visualizing 3D scanned orthodontic models, virtual planning of orthodontic treatments by simulating tooth movements and design of a variety of orthodontic appliances based on 3D scanned orthodontic models.
After the plan is developed by Inman Orthodontic Lab, the prescribing dental clinician reviews and approves the model scheme before the molds are produced. Following approval, the customized aligner trays are fabricated by Inman Orthodontic Lab by press thermoforming of the material on the molds using standard thermoforming equipment. The trays are provided to the dental clinician who provides them to the patient assuring fit and function during the entire treatment period.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
intraoral scans or physical impressions
Anatomical Site
teeth
Indicated Patient Age Range
patients with permanent dentition (i.e. all second molars)
Intended User / Care Setting
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance Testing Laboratory Testing
Test data were submitted to:
- assure the mechanical properties of the aligner material meet specifications for up to 5 years shelf life [according to ASTM D638 standard's testing for: tensile strength (PSI), elongation (%), tensile@ yield (PSI), elongation @ yield (PSI) and tensile modulus (PSI)];
- assure the aligner material packaging retains the required moisture barrier properties;
- validate the processes used for the design and manufacture of the customized aligners, to ensure consistency between the aligner's digital design and the manufactured aligners.
All testing met the pre-determined acceptance criteria.
Biocompatibility
The thermoplastic polyurethane used for making the aligner series has been tested according to Good Laboratory Practices for its biocompatibility according to ISO 10993, as follows: Part 3 (Bacterial Mutagenicity - Ames Assay), Part 5 (Cytotoxicity Elution - MEM), Part 10 (Intracutaneous/Intradermal Reactivity), Part 10 (Oral Mucosa; Irritation), Part 10 (Maximization for Delayed-Type Hypersensitivity). Part 11 (Subacute Intraperitoneal Toxicity)
All testing showed that the material met the requirements of the test methods and is safe and biocompatible for the stated intended use.
Animal | Human Testing
Neither animal nor human testing are needed for this device because it is composed of the same materials, is designed similarly, and is manufactured by a similar method as the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K113618, ClearCorrect System, ClearCorrect, LLC
Reference Device(s)
K152086, 3Shape OrthoSystem™, 3Shape A/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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September 29, 2021
Inman Orthodontic Laboratories, Inc. % Patsy Trisler Regulatory Consultant Trisler Consulting 7949 Beaumont Green East Drive Indianapolis, Indiana 46250
Re: K210763
Trade/Device Name: Inman Digital Clear Aligners Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: Class II Product Code: NXC Dated: August 30, 2021 Received: September 1, 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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 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 (OS) 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,
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) K210763
Device Name
Inman Digital Clear Aligners
Indications for Use (Describe)
Inman Digital Clear Aligners are indicated for the treatment of tooth malocclusions in patients with permanent dentition (i.e. all second molars). The Inman Digital Clear Aligners position 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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510(k) Summary – K210763
| Submitter Name: | Inman Orthodontic Laboratories, Inc. |
|---|---|
| Submitter Address: | 3953 NW 126th Avenue |
| Coral Springs, FL 33065 | |
| Phone Number: | 800-289-0118 |
| Contact Person: | Donal P Inman, President |
| Date Prepared: | September 21, 2021 |
| Device Trade Name: | Inman Digital Clear Aligners |
| Common Name | Aligner, Sequential |
| Classification Name | |
| Number | Orthodontic Plastic Bracket |
| 21 CFR 872.5470 | |
| Product Code | NXC |
| Regulatory Class | 2 |
| Primary Predicate Device: | K113618, ClearCorrect System, ClearCorrect, LLC |
| Reference Device | K152086, 3Shape OrthoSystem™, 3Shape A/S |
| Indications for Use | Inman Digital Clear Aligners are indicated for the treatment of |
| tooth malocclusions in patients with permanent dentition (i.e. all | |
| second molars). The Inman Digital Clear Aligners position teeth | |
| by way of continuous gentle force. | |
| Device Description, | |
| and Summary of | |
| Technological | |
| Characteristics | The Inman Digital Clear Aligners consist of a series of dental- |
| clinician prescribed customized clear plastic removable | |
| orthodontic aligner trays that are made from a clear, thin | |
| thermoformed polyurethane. | |
| A dental clinician prescribes the aligners based on an evaluation | |
| of the patient's teeth. Either intraoral scans or physical | |
| impressions of the patient's teeth are provided to Inman | |
| Orthodontic Lab by the dental clinician, along with the | |
| prescription. The series of plastic aligner trays are designed | |
| according to the prescription using standard dental software for | |
| planning the tooth alignments. | |
| The software used is 3Shape Ortho System (Reference device | |
| K152086). It is used for managing 3D scanned orthodontic | |
| models, orthodontic diagnosis by measuring, analyzing, inspecting | |
| and visualizing 3D scanned orthodontic models, virtual planning of | |
| orthodontic treatments by simulating tooth movements and design | |
| of a variety of orthodontic appliances based on 3D scanned | |
| orthodontic models. | |
| After the plan is developed by Inman Orthodontic Lab, the | |
| prescribing dental clinician reviews and approves the model |
4
scheme before the molds are produced. Following approval, the customized aligner travs are fabricated by Inman Orthodontic Lab by press thermoforming of the material on the molds using standard thermoforming equipment. The trays are provided to the dental clinician who provides them to the patient assuring fit and function during the entire treatment period. Mechanism of Action The aligners are designed to gradually move the patient's teeth incrementally, repositioning them from their original misaligned state to a more aligned state. This occurs through forces applied by the appliance to the teeth over time until final correction, according to the dental clinician's prescription, has been achieved. Each aliqner tray is worn by patients for approximately 22 hours per day for the prescribed period, until it is time to move to the next tray in the series. Performance Testing Laboratory Testing Test data were submitted to: ■ assure the mechanical properties of the aligner material meet specifications for up to 5 years shelf life [according to ASTM D638 standard's testing for: tensile strength (PSI), elongation (%), tensile@ yield (PSI), elongation @ yield (PSI) and tensile modulus (PSI)]; . assure the aligner material packaging retains the required moisture barrier properties; . validate the processes used for the design and manufacture of the customized aligners, to ensure consistency between the aligner's digital design and the manufactured aligners. All testing met the pre-determined acceptance criteria. Biocompatibility The thermoplastic polyurethane used for making the aligner series has been tested according to Good Laboratory Practices for its biocompatibility according to ISO 10993, as follows: Part 3 (Bacterial Mutagenicity - Ames Assay), Part 5 (Cytotoxicity Elution - MEM), Part 10 (Intracutaneous/Intradermal Reactivity), Part 10 (Oral Mucosa; Irritation), Part 10 (Maximization for Delaved-Type Hvpersensitivity). Part 11 (Subacute Intraperitoneal Toxicity) All testing showed that the material met the requirements of the test methods and is safe and biocompatible for the stated intended use.
5
Animal | Human Testing
Neither animal nor human testing are needed for this device because it is composed of the same materials, is designed similarly, and is manufactured by a similar method as the predicate device.
Comparison to There are no notable differences comparing the Inman Digital Predicate Device: Clear Aligners to the predicate ClearCorrect aligner.
- The intended use is the same. 트
- . The mechanism of action is similar.
- . The polyurethane material used to make the aligners is the same.
- . The method of manufacture for producing the customized clear aligners is similar.
- . The use of software for planning and manufacturing are similar.
Substantial Based on the documentation presented in the 510(k), as summarized above and illustrated in the following comparison Equivalence Conclusion table, it can be concluded that Inman Digital Clear Aligners medical device is substantially equivalent to the predicate device.
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| Trade Name: | Proposed: Inman Digital Clear
Aligner | Predicate: ClearCorrect
System |
|---------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | ТВС | K113618 |
| Manufacturer | Inman Orthodontic Laboratory,
Inc. | ClearCorrect, LLC |
| Classification #
and Name
Product Code
Class | 21 CFR 872.5470
Orthodontic Plastic Bracket
NXC
2 | 21 CFR 872.5470
Orthodontic Plastic Bracket
NXC
2 |
| Indications for
Use | Inman Digital Clear Aligners are
indicated for the treatment of
tooth malocclusions in patients
with permanent dentition (i.e. all
second molars). The Inman
Digital Clear Aligners position
teeth by way of continuous gentle
force. | The ClearCorrect System
indicated for the treatment of
tooth malocclusions in patients
with permanent dentition (i.e. all
second molars). The
ClearCorrect System positions
teeth by way of continuous gentle
force. |
| Mechanism of
Action | Alignment of teeth by application
of continuous gentle force, by
sequential use of preformed
plastic trays. | Alignment of teeth by application
of continuous gentle force, by
sequential use of preformed
plastic trays. |
| Description of
Use | Each preformed plastic tray is
worn by the patient as prescribed
by the dental practitioner, usually
a few weeks prior to using the
next sequential aligner tray. | Each preformed plastic tray is
worn by the patient as prescribed
by the dental practitioner, usually
a few weeks prior to using the
next sequential aligner tray. |
| Material | Thin thermoplastic polyurethane | Thin thermoplastic polyurethane |
| Manufacturing
Method | Thermoforming | Thermoforming |
| Biocompatible | Yes, meets ISO 10993
requirements | Yes, meets ISO 10993
requirements |
| Prescription Use | Yes, Rx Only | Yes, Rx Only |
| Software Used
for Treatment
Planning /
Manufacturing | Yes | Yes |
| Single Patient
Use | Yes | Yes |
| Non-Sterile
Packaging | Yes | Yes |