(55 days)
No
The summary does not mention AI, ML, or any related terms, and the performance studies focus on material properties and manufacturing processes, not algorithmic performance.
Yes
The device is used for the treatment of tooth malocclusions and gradually moves the patient's teeth, which constitutes a therapeutic effect.
No
The device is described as an aligner for treating tooth malocclusions by gradually moving teeth, rather than identifying or characterizing a disease or condition.
No
The device description clearly states that the device consists of "customized clear plastic removable aligners" which are physical, tangible components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- NEOLab Clear Aligners Function: The NEOLab Clear Aligners are physical devices worn in the mouth to mechanically move teeth. They do not analyze any biological specimens from the patient.
- Intended Use: The intended use clearly states treatment of tooth malocclusions, which is a mechanical correction, not a diagnostic process based on analyzing biological samples.
- Device Description: The description focuses on the physical properties and function of the aligners themselves.
- Performance Studies: The performance studies described relate to the mechanical properties, manufacturing process, and biocompatibility of the aligners, not the accuracy of a diagnostic test.
Therefore, NEOLab Clear Aligners fall under the category of a medical device used for treatment, not an In Vitro Diagnostic device.
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
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-polyester resin, and are intended to be worn 22 hours a day. The aligners are designed to gradually move the patient's teeth incrementally, repositioning them from their original misalignment to a more aligned state.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Teeth / dentition
Indicated Patient Age Range
Permanent dentition (i.e. all second molars)
Intended User / Care Setting
Doctor / Dental practitioner
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 Testing
Test data were submitted to:
- Assure the aligner mechanical properties of the aligner material meet specifications for up to 5 years shelf life;
- Validate the processes used for the design and manufacture of the customized aligners.
Biocompatibility
The thermoplastic polyurethane-polyester resin 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.
This testing showed that the material and manufactured aligner met the acceptance criteria, passed the respective tests, and are safe and biocompatible for the stated intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K182826, Ormco™ Spark™ Aligner System, Sybron Dental Specialties
Reference Device(s)
K152086, Ortho System™, 3Shape A/S, K180941, Ortho System™, 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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font below.
January 6, 2021
New England Ortho Lab, Inc Olivia Channon Document Control Coordinator 3 Riverside Drive Andover, Massachusetts 01810
Re: K203339
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: December 7, 2020 Received: December 7, 2020
Dear Olivia Channon:
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 Michael Adjodha Assistant 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)
| Residential Use (Part 21 CFR 601 Subpart E) |
|---|
| Over-The-Counter Use (21 CFR 601 |
Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Premarket Notification: Special 510(k) Submitter: New England Ortho Lab, Inc (NEOLab) NEOLab Clear Aligners, K203339 NXC, Class II Dental
Special 510(k) Summary
| Submitter Name | New England Ortho Lab, Inc |
|---|---|
| Submitter Address | 3 Riverside Dr |
| Andover, MA 01810 | |
| Phone Number | +1 (800) 922 - 6365 |
| Contact Person | Ms. Olivia Channon |
| Document Control Coordinator | |
| olivia@neolab.com | |
| Date Prepared | December 2, 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 | |
| II | |
| Primary Predicate | |
| Device | K182826, Ormco™ Spark™ Aligner System, Sybron Dental Specialties |
| Reference Devices | K152086, Ortho System™, 3Shape A/S |
| K180941, Ortho System™, 3Shape A/S | |
| Statement of Intended | |
| 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. | |
| 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-polyester | |
| resin, and are intended to be worn 22 hours a day. The aligners are designed to | |
| gradually move the patient's teeth incrementally, repositioning them from their | |
| original misalignment to a more aligned state. |
4
patient in sequential stage, and confirms fit and functions and monitors the patient through the entire course of aligner therapy. This summary of technological characteristics is unchanged from the predicate device.
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 Testing
Test data were submitted to:
- Assure the aligner mechanical properties of the aligner material meet specifications for up to 5 years shelf life;
- Validate the processes used for the design and manufacture of the customized aligners.
Biocompatibility
The thermoplastic polyurethane-polyester resin 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.
This testing showed that the material and manufactured aligner met the acceptance criteria, passed the respective tests, and are safe and biocompatible for the stated intended use.
There are no notable differences comparing the NEOLab Clear Aligner to the Ormco™ Comparison to Predicate Device Spark™ Aligner System predicate device:
- The intended use is the same; ●
- The mechanism of action is similar;
- The polyurethane-polyester 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 manufacture is similar.
Substantial Based on the documentation presented in this Special 510(k), as summarized above, it can be concluded that NEOLab Clear Aligners are substantially equivalent to the Equivalence Conclusion predicate device.
5
| Trade Name | NEOLab Clear Aligners | Ormco™ Spark™ Aligner System |
|---|---|---|
| 510(k) Number | K203339 | K182826 |
| Submission | Special 510(k) | Traditional 510(k) |
| Manufacturer | New England Ortho Lab, Inc | Sybron Dental Specialties |
| Classification No. | 21 CFR 852.5470 | 21 CFR 852.5470 |
| Product Code | NXC | NXC |
| Class | II | II |
| 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 Ormco™ Spark™ Aligner System is | |
| indicated for the alignment of teeth | ||
| during orthodontic treatment of | ||
| malocclusion in patients with permanent | ||
| dentition (i.e. all second molars). The | ||
| Ormco™ Spark™ Aligner 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, | ||
| fabricated based on doctor's | ||
| prescription. | Orthodontic tooth movement occurs | |
| through forces applied by the appliance to | ||
| the dentition as each tooth follows the | ||
| programmed displacement based on the | ||
| doctor's prescription. | ||
| Process and | ||
| Method of Use | Scans and prescription are sent to | |
| NEOLab by the doctor. Treatment is | ||
| planned by NEOLab, and reviewed and | ||
| approved by doctor. Aligners are | ||
| fabricated and shipped to doctor. Each | ||
| preformed plastic tray is worn by the | ||
| patient as prescribed by the dental | ||
| practitioner. | Doctor uploads patient's dental scans into | |
| proprietary software; doctor uses | ||
| software for case viewing and treatment | ||
| planning; Ormco technician receives case | ||
| and uses proprietary 3D software to | ||
| generate models or the aligners based on | ||
| the prescription (desired outcome); | ||
| Doctor approves treatment plan and final | ||
| treated state; manufacturer crafts and | ||
| produces aligners; aligners and ships them | ||
| to doctor, who them provides them to the | ||
| patient, confirming fit and design. | ||
| Material | Thermoplastic polyurethane-polyester | |
| composite resin | Thermoplastic polyurethane-polyester | |
| composite resin | ||
| Biocompatible | Yes | Yes |
| OTC or Rx | Rx | Rx |
| Software Use | Yes | Yes |
| Sterile | No | No |