(113 days)
No
The summary describes a physical medical device (clear aligners) and its manufacturing process, which involves creating molds and thermoforming plastic. There is no mention of software, algorithms, or data processing that would indicate the use of AI or ML. The process described is based on physical manipulation of models and standard manufacturing techniques.
Yes
The device is described as a series of clear, lightweight, plastic retainers indicated for use in the alignment of teeth through orthodontic treatment of misalignment and malocclusion, actively moving teeth to a final, treated state. This aligns with the definition of a therapeutic device, which is used to treat or alleviate a medical condition.
No
The DynaFlex® Clear Aligner is indicated for the alignment of teeth through orthodontic treatment of misalignment and malocclusion, which is a therapeutic function, not a diagnostic one. It moves teeth progressively to a final, treated state.
No
The device description explicitly states it is a series of clear, lightweight, plastic retainers manufactured from medical grade thermoplastic. This is a physical, hardware component, not software.
Based on the provided information, the DynaFlex® Clear Aligner is 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, or tissue) to provide information for diagnosis, monitoring, or screening.
- DynaFlex® Clear Aligner Function: The DynaFlex® Clear Aligner is a physical device used in the mouth to mechanically move teeth for orthodontic treatment. It does not analyze any biological specimens.
- Intended Use: The intended use clearly states "alignment teeth through orthodontic treatment of misalignment and malocclusion in patients by moving teeth progressively to a final, treated state." This is a therapeutic, not diagnostic, function.
- Device Description: The description focuses on the physical properties of the aligner, how it's fabricated, and how it applies force to the teeth. There is no mention of analyzing biological samples.
Therefore, the DynaFlex® Clear Aligner falls under the category of a medical device used for treatment, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
DynaFlex Clear Aligner is a series of clear, lightweight, plastic retainers indicated for use in the alignment teeth through orthodontic treatment of misalignment and malocclusion in patients by moving teeth progressively to a final, treated state.
Product codes
NXC
Device Description
DynaFlex ® Clear Aligner Appliance is a series of clear, lightweight, plastic retainers indicated for use in the alignment of permanent teeth through orthodontic treatment of misalignment and malocclusion in patients by moving teeth progressively to a final, treated state.
The device will be patient-specific and will be sold by prescription. The device is manufactured with medical grade thermo plastic that is standard throughout the industry.
Aligners are fabricated from .030 thermoformed plastic. The mechanism of force application to the teeth is via intentional distortion of the plastic as the aligners are seated in the mouth. Each subsequent aligner in the overall progressive series is made from a mold of the patient's teeth which reflect subtle changes in the teeth from the previous aligner. The positional changes are introduced into each aligner in the laboratory by moving the teeth on the construction model and then forming the aligner on the same model. The overall treatment is prescribed by the dentist to the laboratory where they are fabricated.
Aligners may be adjusted by the dentist. Aligners are completely removable by the patient and treatment may be discontinued at any time. The appliance if provided as a non-sterile device and single use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
teeth
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Dental health care professional (e.g. Orthodontist or dentist); laboratory
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)
Bench testing of the Aligners has not been performed; however, there is sufficient information available from the scientific literature & other legally FDA cleared device of similar characteristics and material to demonstrate that the preformed aligner provides reasonable assurance of effectiveness.
Non-Clinical Performance Testing: DynaFlex completed a number of non-clinical performance tests. The DynaFlex Clear Aligner meets all the requirements for overall design, biocompatibility, and performance results confirming that the design output meets the design inputs and specifications for the device. The DynaFlex Clear Aligner passed all the testing in accordance with internal requirements, national standards, and international standards to support substantial equivalence of the subject device.
Manufacturing Process Flow validation was performed to ensure that the finished device matches the specification of the doctors' requirements. The output and work model and aligner were tested and compared. DynaFlex Clear Aligners met the specifications of this testing.
Biocompatibility testing per ISO 10993-1 and its applicable parts, as appropriate for the aligner contact and duration.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(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 shows 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. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
June 27, 2019
DynaFlex Matthew Malabey Quality & Regulatory Director 10403 International Plaza Dr. St. Ann, Missouri 63074
Re: K190583
Trade/Device Name: DynaFlex Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: Class II Product Code: NXC Dated: March 25, 2019 Received: March 25, 2019
Dear Matthew Malabey:
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,
Srinivas Nandkumar, Ph.D. Acting 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) K190583
Device Name DynaFlex® Clear Aligner
Indications for Use (Describe)
DynaFlex® Clear Aligner is a series of clear, lightweight, plastic retainers indicated for use in the alignment teeth through orthodontic treatment of misalignment and malocclusion in patients by moving teeth progressively to a final, treated state.
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) |
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
Image /page/3/Picture/0 description: The image shows the logo for DynaFlex, a company that provides orthodontic solutions. The logo consists of a stylized white graphic to the left, followed by the company name in bold, red letters. Below the company name is the tagline "Your Total Orthodontic Solution!" in a smaller, green font.
510(k) Summary (K190583)
Submitter:
DynaFlex 10403 International Plaza Dr. St. Ann, MO 63074
Contact:
Matthew Malabey Quality & Regulatory DynaFlex 314-426-4020- Phone 314-429-7575- Fax
Date Summary Prepared: J June 26, 2019
Device Name:
- Trade Name DynaFlex Clear Aligner ●
- Classification name - Sequential Aligner
- Regulation Description - Orthodontic plastic bracket
- Definition - The device moves by gentle force for treatment of minor tooth malocclusion
- Regulation Medical Specialty - Dental
- Review Panel - Dental
- Product Code - NXC
- Regulation Number 21 CFR§ 872.5470
- . Device Class - 2
Devices for Which Substantial Equivalence is Claimed:
- Primary Predicate: Specialty Appliance Works, Inc.— Clear Image™ Aligner . (K071970)
- Reference Device: Clear Correct, Inc.- Clear Correct (K082556) ●
4
Image /page/4/Picture/0 description: The image displays the logo for "DynaFlex", a company that provides orthodontic solutions. The logo features a stylized graphic to the left of the company name, both rendered in red. Below the company name, the tagline "Your Total Orthodontic Solution!" is written in a smaller, bolder font, emphasizing the company's focus on comprehensive orthodontic services.
Device Description:
DynaFlex ® Clear Aligner Appliance is a series of clear, lightweight, plastic retainers indicated for use in the alignment of permanent teeth through orthodontic treatment of misalignment and malocclusion in patients by moving teeth progressively to a final, treated state.
The device will be patient-specific and will be sold by prescription. The device is manufactured with medical grade thermo plastic that is standard throughout the industry.
Aligners are fabricated from .030 thermoformed plastic. The mechanism of force application to the teeth is via intentional distortion of the plastic as the aligners are seated in the mouth. Each subsequent aligner in the overall progressive series is made from a mold of the patient's teeth which reflect subtle changes in the teeth from the previous aligner. The positional changes are introduced into each aligner in the laboratory by moving the teeth on the construction model and then forming the aligner on the same model. The overall treatment is prescribed by the dentist to the laboratory where they are fabricated.
Aligners may be adjusted by the dentist. Aligners are completely removable by the patient and treatment may be discontinued at any time. The appliance if provided as a non-sterile device and single use.
Indications for Use:
DynaFlex ® Clear Aligner Appliance is a series of clear, lightweight, plastic retainers indicated for use in the alignment of permanent teeth through orthodontic treatment of misalignment and malocclusion in patients by moving teeth progressively to a final, treated state. DynaFlex Clear Aligner is for prescription only.
Summary of Technological Characteristics:
Section 5.0: 510(k) Summary Submitter: DynaFlex® Clear Aligner Premarket Notification: Traditional 510(k): A dental health care professional (e.g. Orthodontist or Technological dentist), prescribes the Clear Aligner system based on an characteristics assessment of the patient's teeth, determines a course of treatment with the system, takes molds of the patient's teeth, and completes a prescription form. The molds and prescription are sent to Dynaflex. DynaFlex designs a series of plastic trays intended to gradually realign the patient's teeth in accordance with the physician's prescription. DynaFlex produces the trays, which are fabricated from .030 thermoformed plastic. The mechanism of force application to the teeth is via intentional distortion of the plastic as the aligners are seated in the mouth. Each subsequent aligner in the overall progressive series is made from a mold of the patient's teeth which reflect subtle changes in the position of the teeth from the previous aligner. The positional changes are introduced into each aligner in the laboratory by moving the teeth on the construction model and then forming the aligner on the model. The overall treatment is prescribed by the dentist to the
5
Image /page/5/Picture/0 description: The image shows the logo for DynaFlex, a company that provides orthodontic solutions. The logo consists of a red square with a white abstract design on the left, followed by the word "DynaFlex" in red, with a registered trademark symbol. Below the logo, the text "Your Total Orthodontic Solution!" is written in black, with a service mark symbol.
laboratory where they are fabricated. This technology is essentially identical to that used by a number of sequential alignment systems, including the predicates referenced above.
Performance Characteristics:
Bench testing of the Aligners has not been performed; however, there is sufficient information available from the scientific literature & other legally FDA cleared device of similar characteristics and material to demonstrate that the preformed aligner provides reasonable assurance of effectiveness.
Non-Clinical Performance Testing
As part of demonstrating substantial equivalence to the predicate devices that are subject to this 510(k) submission. DynaFlex completed a number of non-clinical performance tests. The DynaFlex Clear Aligner meets all the requirements for overall design, biocompatibility, and performance results confirming that the design output meets the design inputs and specifications for the device.
The DynaFlex Clear Aligner passed all the testing in accordance with internal requirements, national standards, and international standards to support substantial equivalence of the subject device.
Manufacturing Process Flow validation was performed to ensure that the finished device matches the specification of the doctors' requirements. The output and work model and aligner were tested and compared. DynaFlex Clear Aligners met the specifications of this testing.
DynaFlex has completed biocompatibility testing per ISO 10993-1 and its applicable parts, as appropriate for the aligner contact and duration. The mechanical properties of the thermoformed plastic has been previously demonstrated by the manufacturer as appropriate for use with aligners, therefore no additional testing was required to demonstrate substantial equivalence.
Substantial Equivalence:
DynaFlex® Clear Aligner is substantially equivalent to other FDA approved legally marketed orthodontic devices in the United States. DynaFlex Clear Aligners is used in a manner similar to the Clear Image™ system (Primary Predicate) marketed by Specialty Appliance Works, Inc., and Clear Correct marketed by Clear Correct, Inc. (Reference Device) The proposed and predicate devices are of similar design; made from virtually identical materials, and are fabricated using similar manufacturing methods that are common to the dental device industry. Furthermore, DynaFlex® Clear Aligner Appliance have the same intended uses as the predicate devices in that they serve as an oral appliance constructed of polymer components that when fabricated into their final form and dimensions, are a dental appliance that are custom fit for the patient. The properties and characteristics of the predicate devices are compared to DynaFlex® Clear Aligner Devices in the Table 12-1.
6
Image /page/6/Picture/0 description: The image features the DynaFlex logo, with a stylized red graphic to the left of the company name in bold, red letters. To the right of the company name is a circled R symbol. Below the company name is the text "Your Total Orthodontic Solution!" in black, with a superscript SM symbol to the right.
| Table 12-1
| Substantial Equivalence Comparison | ||||
|---|---|---|---|---|
| Manufacturer: | DynaFlex® | Specialty Appliances Works, Inc. (Primary Predicate) | ClearCorrect, Inc. (Reference Device) | Comparison |
| Trade Name: | DynaFlex® Clear Aligner | Clear Image™ Aligners | ClearCorrect™ | N/A |
| Product Images: | Image: DynaFlex Aligners | Image: Clear Image Aligners | Image: ClearCorrect Aligners | N/A |
| Product Code: | ||||
| Attach Mechanism: | ||||
| (lower to upper tray) | NXC | |||
| None | NXC | |||
| None | NXC | |||
| None | Same | |||
| Regulation Number: | 872.5470 | 872.5470 | 872.5470 | Same |
| Regulation Name: | Orthodontic plastic bracket | Orthodontic plastic bracket | Orthodontic plastic bracket | Same |
| 510(k): | K190583 | K071970 | K082556 | N/A |
| Indications for Use: | DynaFlex® Clear Aligner | |||
| Appliance is a series of | ||||
| clear, lightweight, plastic | ||||
| retainers indicated for use in | ||||
| the alignment of permanent | ||||
| teeth through orthodontic | ||||
| treatment of misalignment | ||||
| and malocclusion in patients | ||||
| by moving teeth | ||||
| progressively to a final, | ||||
| treated state. DynaFlex | ||||
| Clear Aligner is for | ||||
| prescription only. | Specialty Appliances' | |||
| Clear ImageTM Aligners | ||||
| primarily are directed | ||||
| toward treating a | ||||
| patient's anterior teeth. | ||||
| Such treatment involves | ||||
| the relatively minor | ||||
| orthodontic tooth | ||||
| movements intended to | ||||
| impact a patient's | ||||
| appearance and self | ||||
| image. The Dentist | ||||
| makes final decision | ||||
| and adjustment per | ||||
| treatment plan | The ClearCorrect System | |||
| 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. | ||||
| The Dentist makes final | ||||
| decision and adjustment | ||||
| per treatment plan | Same | |||
| Mechanism of Action: | Basic mechanics follows the | |||
| same principles of | ||||
| conventional orthodontics. | ||||
| The aligners apply a simple | ||||
| force on the tooth. | ||||
| Therefore, the Sequential | ||||
| aligners can produce tipping, | ||||
| rotation, extrusion and | ||||
| intrusion forces. However, | ||||
| the extrusive force from the | ||||
| Sequential Retainers is | Basic mechanics follows | |||
| the same principles of | ||||
| conventional | ||||
| orthodontics. The | ||||
| aligners apply a simple | ||||
| force on the tooth. | ||||
| Therefore, the | ||||
| Sequential aligners can | ||||
| produce tipping, | ||||
| rotation, extrusion and | ||||
| intrusion forces. | Basic mechanics follows | |||
| the same principles of | ||||
| conventional orthodontics. | ||||
| The aligners apply a | ||||
| simple force on the tooth. | ||||
| Therefore, the Sequential | ||||
| aligners can produce | ||||
| tipping, rotation, extrusion | ||||
| and intrusion forces. | Same | |||
| force from the | ||||
| Sequential Retainers is | ||||
| limited. | ||||
| Materials: | ||||
| Stainless Steel: | None | None | None | Same |
| Dental Plastic: | Thermoformed (Plastic) | Thermoformed (Plastic) | Thermoformed (Plastic) | Same |
| Dimensions: | Various | |||
| (see Engineering Drawings) | Various | |||
| (Not available) | Various | |||
| (Not available) | Same | |||
| Supplied Sterile: | No | No | No | Same |
| Single Use: | Yes | |||
| (i.e., multiple use by the | ||||
| same patient) | Yes | |||
| (i.e., multiple use by the | ||||
| same patient) | Yes | |||
| (i.e., multiple use by the | ||||
| same patient) | Same | |||
| Worn at Night: | Yes | Yes | Yes | Same |
| Patient Population | Patient with Permanent | |||
| Dentition | Patient with Permanent | |||
| Dentition | Patient with Permanent | |||
| Dentition | Same | |||
| Physical Properties | Plastic Sheets/Proprietary | Plastic | ||
| Sheets/Proprietary | Plastic Sheets/Proprietary | Same | ||
| Biocompatibility | Passed ISO 10993-1 and | |||
| series | Passed ISO 10993-1 | |||
| and | ||||
| series | Passed ISO 10993-1 and | |||
| series | Same | |||
| Size | Patient specific | Patient specific | Patient specific | Same |
| Material | 0.03" Thermoplastic | 0.03" Thermoplastic | 0.03" Thermoplastic | Same |
| Healthcare | ||||
| Professional | ||||
| Review | The dental practitioner | |||
| reviews aligner | ||||
| series prior to fabrication | ||||
| and has the option to | ||||
| reject or request | ||||
| modifications to the setup | ||||
| prior to approving it | ||||
| for aligner fabrication. | The dental practitioner | |||
| reviews aligner | ||||
| series prior to | ||||
| fabrication | ||||
| and has the option to | ||||
| reject or request | ||||
| modifications to the | ||||
| setup | ||||
| prior to approving it | ||||
| for aligner fabrication. | The dental practitioner | |||
| reviews aligner | ||||
| series prior to fabrication | ||||
| and has the option to | ||||
| reject or request | ||||
| modifications to the setup | ||||
| prior to approving it | ||||
| for aligner fabrication. | Same |
7
Image /page/7/Picture/0 description: The image shows the logo for DynaFlex, a company that provides orthodontic solutions. The logo consists of a stylized red square with white curved lines on the left, followed by the company name "DynaFlex" in bold red letters. Below the company name is the tagline "Your Total Orthodontic Solution!" in a smaller font size.
Substantial Equivalence Conclusion
By definition, a device is substantially equivalent to a predicate device when the device has the same intended use and the same technological characteristics as the previously cleared predicate device. Based on the comparison and analysis above, the DynaFlex Clear Aligner is determined to be substantially equivalent to the referenced predicate device(s).