(269 days)
No
The description focuses on the physical manufacturing process and the use of existing software (K180941) for design based on dentist recommendations, with no mention of AI/ML for treatment planning or other functions.
Yes
The device is indicated for the alignment of teeth during orthodontic treatment of malocclusion, and it positions teeth by applying continuous gentle force, fitting the definition of a therapeutic device.
No
The device, MVP Aligners, is described as a treatment device for the alignment of teeth during orthodontic treatment. While its application is based on a scan or physical impression of the patient's teeth and orthodontist recommendations, its primary function is to physically move teeth, not to provide diagnostic information about a disease or condition. The "Intended Use" clearly states "alignment of teeth during orthodontic treatment," which indicates a therapeutic purpose.
No
The device is a physical medical device (clear plastic aligners) fabricated through a manufacturing process involving 3D printing, thermoforming, and CNC machining. While software is used in the design process, the final device is a tangible product.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "alignment of teeth during orthodontic treatment of malocclusion." This is a direct treatment of a physical condition within the patient's body.
- Device Description: The device is a physical appliance (aligners) that applies force to the teeth. It is fabricated based on a physical impression or scan of the patient's teeth, but it does not analyze biological samples or provide diagnostic information.
- Lack of Diagnostic Function: The device's function is to physically move teeth, not to diagnose a disease or condition, monitor a physiological process, or determine compatibility with a treatment.
- Input: The input is a physical representation of the teeth (scan or impression), not a biological sample like blood, urine, or tissue.
- Anatomical Site: The anatomical site is the teeth and jaw, which are part of the patient's body, not a sample taken from the body.
IVD devices are used to examine specimens derived from the human body (like blood, urine, or tissue) to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not perform any of these functions on a biological specimen.
N/A
Intended Use / Indications for Use
The MVP Aligners are indicated for the alignment of teeth during orthodontic treatment of malocclusion in patients with permanent dentition (i.e., all second molars). The MVP Aligners position teeth by way of continuous gentle force.
Product codes (comma separated list FDA assigned to the subject device)
NXC
Device Description
The MVP Aligner system is a prescription (Rx) device comprised of a series of dentist prescribed clear, biocompatible, plastic shells that fit over the teeth designed to incrementally improve malocclusion by providing progressive force and moving patient dentition from an initial condition to a preferred corrected condition. After a scan or physical impression of the patient's teeth is taken by or under the direct supervision of the patient's orthodontically trained dentist, each aligner in the sequential set is created by a trained technician utilizing Ortho System software (K180941) according to the orthodontic screening and tooth movement recommendations provided by the same prescribing orthodontically trained dentist. The recommendations are patient specific and can only be relied upon for an individual patient for whom the device is prescribed. Furthermore, the orthodontically trained dentist reviews and approves the model scheme before the molds are produced. Once approved, the trays which are formed of clear, thin, thermoformed plastic are fabricated.
The indirect fabrication process involves a 3D print of a plastic model representing the patient specific upper and lower dentition of the patient's jaw. The models are cured. Biocompatible plastic sheets are thermoformed over the cured models with pressure and heat, marked with a patient identifier on the occlusal surface, and trimmed in a 5-axis CNC machine. The aligner containing an individualized trim line is polished, cleaned, sorted and packaged with a UDI.
MVP Aligners are provided non-sterile and are completely removable by the patient. Once approved, the trays are sent back to the orthodontically trained dentist who then provides them to the patient, in sequential stages confirming fit and design. The orthodontically trained dentist monitors treatment from the delivery of the first to final aligner.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
scan or physical impression
Anatomical Site
Teeth, dentition
Indicated Patient Age Range
patients with permanent dentition (i.e., all second molars)
Intended User / Care Setting
Orthodontically trained dentist, prescription (Rx) device
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)
Clinical Data: The performance of sequential aligners in the clinical environment has been well established since the first aligners were cleared by the FDA under product code NXC in 1998. There is sufficient information available from scientific literature to support safety and efficacy. Therefore, clinical testing was not necessary to demonstrate substantial equivalence of the MVP Aligners to the predicate device.
Manufacturing/Mechanical: The material properties of thermoplastic polyurethane have been received from and demonstrated by the manufacturer through biocompatability, crack resistance and stress relaxation testing and have been proven effective with over eight years of clinical use in the clear aligner field. Validation and verification tests confirmed the accuracy of each step of the manufacturing process and that the clarity and fit met the predetermined requirements.
Non-clinical data
Biocompatatility: Biocompatibility of the base plastic was evaluated by the manufacturer according to ISO 10993-1, including cytotoxicity (ISO 7405 6.2, 6.3 and ISO 10993-5), delayed-type hypersensitivity (ISO 10993-10), irritation (ISO 10993-10), acute systems toxicity (ISO 10993-11), subchronic systemic toxicity (ISO 10993-11) and genotoxicity (ISO 10993-3).
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.
Ormco K182826
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.
3Shape K180941, Clearcorrect K113618
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
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August 7, 2020
MVP Aligners, LLC % Prithul Bom Responsible Third Party Official Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k Saint Paul, Minnesota 55114
Re: K193130
Trade/Device Name: MVP Aligner System Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic plastic bracket Regulatory Class: Class II Product Code: NXC Dated: July 28, 2020 Received: August 3, 2020
Dear Prithul Bom:
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.
1
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 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 medical devices and radiation-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,
Srinivas 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)
K193130
Device Name MVP Aligner System
Indications for Use (Describe)
The MVP Aligners are indicated for the alignment of teeth during orthodontic treatment of malocclusion in patients with permanent dentition (i.e., all second molars). The MVP 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 K193130
| Date Prepared: | September 1, 2019 | | MVP Aligner System | Ormco (predicate)
(K182826) | ClearCorrect (reference)
(K113618) |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | MVP Aligners
5-9 Union Square West, 7th Floor
New York, NY 10003 | Indications for Use | The MVP Aligners are
indicated for the
alignment of teeth during
orthodontic treatment of
malocclusion in patients
with permanent dentition
(i.e., all second molars).
The MVP Aligners
position teeth by way of
continuous gentle force. | The OrmcoTM SparkTM
Aligner System is indicated
for the alignment of teeth
during orthodontic treatment
of malocclusion in patients
with permanent denitition (i.e.,
all second molars). The
OrmcoTM SparkTM Aligner
System positions teeth by way
of continuous gentle force. | ClearCorrectSystem is indicated for
the treatment of tooth malocclusion
in patients with permanent dentition
(i.e. all second molars). The
ClearCorrect System positions teeth
by way of continuous gentle force. |
| Contact: | Jim Churchill
1 (831) 247-1415 | Product Code | NXC | NXC | NXC |
| Proprietary Name: | MVP Aligner System | Classification | 872.5470 | 872.5470 | 872.5470 |
| Common Name: | Sequential Aligners | Material | Thermoplastic
polyurethane | Thermoplastic
Polyurethane | Thermoplastic polyurethane |
| Classification: | 21 CFR 872.5470: Orthodontic plastic bracket; Class II | Mode of Action | Continuous gentle force
applied to teeth to
achieve movement.
Orthodontic tooth
movement occurs through
forces applied by the
appliance to the dentition
as each tooth follows the
programmed
displacement based on a
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 a doctor's
prescription. | Continuous gentle force
applied to teeth to achieve movement |
| Predicate Device | Ormco K182826 | Patient Removable | Yes | Yes | Yes |
| Reference Device(s): | 3Shape K180941, Clearcorrect K113618 | Duration of use | 20-22 hours/day | 20-22 hours/day | 20-22 hours/day |
| Biocompatability | cytotoxicity (ISO 7405 6.2,
6.3 and ISO 10993-5),
delayed-type hypersensitivity
(ISO 10993-10), irritation
(ISO 10993-10), acute systems
toxicity (ISO 10993-11),
subchronic systemic toxicity
(ISO 10993-11) and
genotoxicity (ISO 10993-3) | ISO 7405:2008 Dentistry -
Evaluation of biocompatibility
of medical devices used in
dentistry | ISO 10993-5 Cytotoxicity, ISO
10993-10 Intracutaneous reactivity,
oral mucosa irritation test, maximum
test for delayed type hypersensitivity | | |
| OTC or Rx | Rx | Rx | Rx | | |
The MVP Aligner system is a prescription (Rx) device comprised of a Device Description: series of dentist prescribed clear, biocompatible, plastic shells that fit over the teeth designed to incrementally improve malocclusion by providing progressive force and moving patient dentition from an initial condition to a preferred corrected condition. After a scan or physical impression of the patient's teeth is taken by or under the direct supervision of the patient's orthodontically trained dentist, each aligner in the sequential set is created by a trained technician utilizing Ortho System software (K180941) according to the orthodontic screening and tooth movement recommendations provided by the same prescribing orthodontically trained dentist. The recommendations are patient specific and can only be relied upon for an individual patient for whom the device is prescribed. Furthermore, the orthodontically trained dentist reviews and approves the model scheme before the molds are produced. Once approved, the trays which are formed of clear, thin, thermoformed plastic are fabricated.
The indirect fabrication process involves a 3D print of a plastic model representing the patient specific upper and lower dentition of the patient's jaw. The models are cured. Biocompatible plastic sheets are thermoformed over the cured models with pressure and heat, marked with a patient identifier on the occlusal surface, and trimmed in a 5-axis CNC machine. The aligner containing an individualized trim line is polished, cleaned, sorted and packaged with a UDI.
MVP Aligners are provided non-sterile and are completely removable by the patient. Once approved, the trays are sent back to the orthodontically trained dentist who then provides them to the patient, in sequential stages confirming fit and design. The orthodontically trained dentist monitors treatment from the delivery of the first to final aligner.
Indications for use / Intended use: The MVP Aligners are indicated for the alignment of teeth during orthodontic treatment of malocclusion in patients with permanent dentition (i.e., all second molars). The MVP Aligners position teeth by way of continuous gentle force.
Clinical Data: The performance of sequential aligners in the clinical environment has been well established since the first aligners were cleared by the FDA under product code NXC in 1998. There is sufficient information available from scientific literature to support safety and efficacy. Therefore, clinical testing was not necessary to demonstrate substantial equivalence of the MVP Aligners to the predicate device.
4
Manufacturing/Mechanical: The material properties of thermoplastic polyurethane have been received from and demonstrated by the manufacturer through biocompatability, crack resistance and stress relaxation testing and have been proven effective with over eight years of clinical use in the clear aligner field. Validation and verification tests confirmed the accuracy of each step of the manufacturing process and that the clarity and fit met the predetermined requirements.
Non-clinical data
Biocompatatility: Biocompatibility of the base plastic was evaluated by the manufacturer according to ISO 10993-1, including cytotoxicity (ISO 7405 6.2, 6.3 and ISO 10993-5), delayed-type hypersensitivity (ISO 10993-10), irritation (ISO 10993-10), acute systems toxicity (ISO 10993-11), subchronic systemic toxicity (ISO 10993-11) and genotoxicity (ISO 10993-3).
Summary of Substantial Equivalence: The MVP Aligner system has the identical indications for use as the Ormoo aligner system (K182826). The MVP Aligner, has the same mode of action, duration of use, is similarly patient removable, and utilizes the same base material, which has passed biocompatibility testing both in its native form and as a finished medical device, as was cleared by Ormco (K182826) and Clearcorrect (K113618). Based on a comparison of these factors, we believe that the MVP Aligner system is substantially equivalent to the predicate.