(197 days)
No
The summary describes a traditional process for designing and manufacturing clear aligners based on scans or impressions, without mentioning any AI/ML involvement in treatment planning or design.
Yes
The device is described as treating "tooth malocclusions" and "repositioning them from their original misalignment to a more aligned state" through "continuous gentle force," which indicates a therapeutic purpose.
No
Explanation: This device is an orthodontic aligner used for treating tooth malocclusions by repositioning teeth. Its purpose is therapeutic, not diagnostic.
No
The device description clearly states that the device consists of "a series of customized clear plastic removable aligners that are fabricated from a clear, thin thermoformed polyurethane." This indicates a physical, hardware component. While software is used in the design and manufacturing process, the final 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:
- Intended Use: The intended use is to treat tooth malocclusions by physically moving teeth. This is a therapeutic intervention, not a diagnostic test performed on a sample from the human body.
- Device Description: The device is a physical appliance (clear aligners) that is placed in the mouth to exert force on teeth. It does not analyze biological samples or provide diagnostic information.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples (blood, urine, tissue, etc.), diagnostic markers, or the provision of information for diagnosis, monitoring, or prognosis of a disease or condition.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic purposes. This device is a medical device used for treatment.
N/A
# Intended Use / Indications for Use
NEOLab Clear Aligners are indicated for the treatment of tooth malocclusions in patients with permanent dentition (i.e. all second molars). The NEOLab Clear Aligners position teeth through the use of continuous gentle force.
# Product codes (comma separated list FDA assigned to the subject device)
NXC
# Device Description
NEOLAB Clear Aligners consist of a series of customized clear plastic removable aligners that are fabricated from a clear, thin thermoformed polyurethane. The aligners are designed to gradually move the patient's teeth incrementally, repositioning them from their original misalignment to a more aligned state.
The aligners, customized for each patient's prescription, are designed and manufactured based on either standard impressions or intraoral scans taken by the dental clinician and which are then sent to the company. The aligners are then sent back to the dental clinician who then distributes them in sequential stages to the patient and follows up with the patient through orthodontic examinations to check device fit and function.
During manufacturing, models are made from physical impressions or intraoral scans. Those made from stone or plaster impressions are scanned into the computer and made into digital files. The intraoral scans arrive as digital files. The digital files are 3D printed and are used to produce the aligner series with the thermoplastic polyurethane.
# Mentions image processing
Not Found
# Mentions AI, DNN, or ML
Not Found
# Input Imaging Modality
Not Found
# Anatomical Site
tooth
# 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)
Laboratory/Bench 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) - testing included: tensile strength (PSI) elongation (%) tensile @ yield (PSI) elongation @ yield (PSI) 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 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 Systemic Toxicity)
Further, the finished customized aligner was tested according to ISO 10993, Part 5, Cytotoxicity. Results show it is non-cytotoxic.
All testing showed that the material and manufactured aligner met the requirements of the test methods and are safe and biocompatible for the stated intended use.
# 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.
[K113618](https://510k.innolitics.com/search/K113618), ClearCorrect System, ClearCorrect, LLC
# 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.
[K152086](https://510k.innolitics.com/search/K152086), Ortho System™, 3Shape A/S, [K180941](https://510k.innolitics.com/search/K180941), Ortho System™ , 3Shape A/S
# 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 of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Thursday, March 12, 2020
New England Ortho Lab, Inc. % Patsy Trisler Regulatory Consultant Oserve Group US, Inc. 7949 Beaumont Green East Drive Indianapolis, Indiana 46250
Re: K192338
Trade/Device Name: NEOLab Clear Aligners Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: Class II Product Code: NXC Dated: February 21, 2020 Received: February 24, 2020
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,
For Srivinas '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) K192338
Device Name
NEOLab Clear Aligners
Indications for Use (Describe)
NEOLab Clear Aligners are indicated for the treatment of tooth malocclusions in patients with permanent dentition (i.e. all second molars). The NEOLab Clear Aligners position teeth through the use 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
| Submitter Name: | New England Ortho Lab, Inc. |
|---|---|
| Submitter Address: | 3 Riverside Drive |
| Andover, MA 01810 | |
| Phone Number: | 1-800-922-6365 |
| Contact Person: | Ms. Olivia Channon |
| Document Control Coordinator | |
| Date Prepared: | February 21, 2020 |
| Device Trade Name: | NEOLab Clear Aligners |
| Common Name | Aligner, Sequential |
| Classification Name | |
| Number | |
| Product Code | |
| Regulatory Class | Orthodontic Plastic Bracket |
| 21 CFR 872.5470 | |
| NXC | |
| 2 | |
| Primary Predicate | |
| Device: | K113618, ClearCorrect System, ClearCorrect, LLC |
| Reference Devices: | K152086, Ortho System™, 3Shape A/S |
| K180941, Ortho System™ , 3Shape A/S | |
| Indications for Use | |
| Statement | NEOLab Clear Aligners are indicated for the treatment of tooth |
| malocclusions in patients with permanent dentition (i.e. all second | |
| molars). The NEOLab Clear Aligners position teeth through the | |
| use of continuous gentle force. | |
| Device Description | |
| and Summary of | |
| Technological | |
| Characteristics | NEOLAB Clear Aligners consist of a series of customized clear |
| plastic removable aligners that are fabricated from a clear, thin | |
| thermoformed polyurethane. The aligners are designed to | |
| gradually move the patient's teeth incrementally, repositioning | |
| them from their original misalignment to a more aligned state. |
The aligners, customized for each patient's prescription, are
designed and manufactured based on either standard impressions
or intraoral scans taken by the dental clinician and which are then
sent to the company. The aligners are then sent back to the
dental clinician who then distributes them in sequential stages to
the patient and follows up with the patient through orthodontic
examinations to check device fit and function.
During manufacturing, models are made from physical
impressions or intraoral scans. Those made from stone or plaster
impressions are scanned into the computer and made into digital
files. The intraoral scans arrive as digital files. The digital files
are 3D printed and are used to produce the aligner series with the
thermoplastic polyurethane. |
| The thermoplastic material used for fabrication of the aligners is
commonly used in many dental appliances, including the
predicate aligners. | |
| Mechanism of
Action | Based on the clinician's treatment plan, each aligner is used for a
defined period of time to exert gentle force to achieve progressive
realignment of the teeth. This occurs over time until the final
correction has been achieved. |
| Device Testing | Laboratory/Bench 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) - testing included: tensile strength (PSI) elongation (%) tensile @ yield (PSI) elongation @ yield (PSI) 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 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 Systemic Toxicity)
Further, the finished customized aligner was tested according to
ISO 10993, Part 5, Cytotoxicity. Results show it is non-cytotoxic.
All testing showed that the material and manufactured aligner met
the requirements of the test methods and are safe and
biocompatible for the stated intended use. |
| | Animal Human Testing
Neither animal nor human testing are required for this product
because it is composed of the same materials, is designed
similarly, and is manufactured by a similar method as the predicate
device. |
| Comparison to
Predicate Device: | There are no notable differences comparing the NEOLab clear
aligner to the ClearCorrect predicate device:
The intended use is the same. The mechanism of action is similar. The polyurethane material used to make the aligners is the same. The method of manufacture and customizing the aligners is similar. The use of software for planning and manufacturing are similar. Refer to the Substantial Equivalence Comparison table below for a
side-by-side comparison of the indications for use, technological
characteristics, materials and principles of operation. |
| Substantial
Equivalence
Conclusion: | As presented in the 510(k) and summarized herein, it can be
concluded that NEOLab Clear Aligner is substantially equivalent to
the predicate device. |
4
5
I
6
| Trade Name: | NEOLab Aligner System | ClearCorrect System |
|---|---|---|
| 510(k) Number | K1923338 | K113618 |
| Manufacturer | New England Ortho Lab, Inc. | ClearCorrect, LLC |
| Classification # & | ||
| Product Code | ||
| Class | 21 CFR 852.5470 | |
| NXC | ||
| 2 | 21 CFR 852.5470 | |
| NXC | ||
| 2 | ||
| Indications for | ||
| Use | NEOLab Clear Aligners are | |
| indicated for the treatment of | ||
| tooth malocclusion in patients | ||
| with permanent dentition (i.e. all | ||
| second molars). The NEOLab | ||
| Clear Aligners position teeth by | ||
| way of continuous gentle force. | The ClearCorrect System is | |
| indicated for the treatment of | ||
| tooth malocclusion in patients | ||
| with permanent dentition (i.e. all | ||
| second molars). The Clear | ||
| Correct System positions teeth by | ||
| way of continuous gentle force. | ||
| Mode 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. | ||
| Method 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 thermoformed | |
| polyurethane | Thin thermoformed polyurethane | |
| Biocompatible | Yes | Yes |
| OTC or Rx | Rx | Rx |
| Software Use | Yes | Yes |
| Sterile | No | No |