(301 days)
Not Found
No
The summary describes a physical device (aligners) and mentions software for fabrication based on a treatment plan, but there is no mention of AI or ML being used for treatment planning, image analysis, or any other function.
Yes
The device is indicated for the treatment of tooth malocclusion, which is a medical condition, and it functions by applying force to reposition teeth, thereby providing a therapeutic effect.
No
Explanation: The device is an aligner used for treating tooth malocclusion by repositioning teeth. It is a therapeutic device, not a diagnostic one as it does not diagnose a condition.
No
The device description explicitly states the device is fabricated of "clear thin thermoformed polyurethane plastic," indicating it is a physical, hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens from the human body. The intended use and device description clearly state that the Park Dental Research Aligners are used to reposition teeth directly in the patient's mouth. They do not involve the analysis of biological samples like blood, urine, or tissue.
- The purpose is mechanical repositioning, not diagnosis. The device applies force to move teeth, which is a mechanical process for treatment, not a diagnostic test to identify a disease or condition.
Therefore, the Park Dental Research 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
Park Dental Research Aligners are indicated for the treatment of tooth malocclusion in patients with permanent dentition (i.e. all second molars). Park Dental Research Aligners positions teeth by way of continuous gentle force.
Product codes
NXC
Device Description
The Park Dental Research Aligners device is fabricated of clear thin thermoformed polyurethane plastic in a sequential series to progressively reposition the teeth. Corrective force to straighten the teeth is delivered via minor changes into a position in each subsequent aligner.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
teeth
Indicated Patient Age Range
patients with permanent dentition (i.e. all second molars)
Intended User / Care Setting
Not Found
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)
Non-Clinical Performance Testing: The material used for the Park Dental Research aligners is the same polyurethane material as used in the predicate device ClearCorrect System. It is called Zendura. A biocompatibility assessment determined no testing was needed since the material is the same as the predicate device. Park Dental Research conducted manufacturing validation with software to be used to fabricate the aligners and based upon the predetermined treatment plan.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K113618 ClearCorrect System from ClearCorrect LLC
Reference Device(s)
Not Found
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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510(k) Summary
K180648
Park Dental Research Aligners
Park Dental Research Corporation
Trade Name: Park Dental Research Aligners
Common Name: Sequential Aligner
Date of Preparation: November 28, 2018
Submitter: Dr. Ronald A Bulard
Submitter's Address: 2401 N. Commerce St. Suite E Ardmore, OK 73401
Submitter's Phone: 800-243-7372
Product Code: NXC
Regulation No.: 872.5470 Orthodontic Plastic Bracket
Classification: Class II
Predicate 510k: K113618 ClearCorrect System from ClearCorrect LLC
Device Description:
The Park Dental Research Aligners device is fabricated of clear thin thermoformed polyurethane plastic in a sequential series to progressively reposition the teeth. Corrective force to straighten the teeth is delivered via minor changes into a position in each subsequent aligner.
Indications for Use:
Park Dental Research Aligners are indicated for the treatment of tooth malocclusion in patients with permanent dentition (i.e. all second molars). Park Dental Research Aligners positions teeth by way of continuous gentle force.
The indications for use is highly similar to that of the predicate device, ClearCorrect, with the differences due to including the device name.
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Technological Characteristics:
Treatment of tooth malocclusions via a series of intraoral plastic appliances designed to provide forces for incremental movement of targeted teeth to a desired final position is the technological principle for both the subject device and the predicate device.
Mechanism of Action:
The mechanism of action is similar to the predicate devices. Orthodontic targeted tooth movement occurs through forces applied by the appliance to the dentition as each tooth follows the programmed displacement based on a dental health professional's prescription.
Non-Clinical Performance Testing:
The material used for the Park Dental Research aligners is the same polyurethane material as used in the predicate device ClearCorrect System. It is called Zendura. A biocompatibility assessment determined no testing was needed since the material is the same as the predicate device. Park Dental Research conducted manufacturing validation with software to be used to fabricate the aligners and based upon the predetermined treatment plan.
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Predicate Device Comparison Table
| | Park Dental Research Aligners
K180648 | ClearCorrect System from ClearCorrect
K113618 |
|-----------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulation
Number | 21 CFR 872.5470 | 21 CFR 872.5470 |
| Device
Classification
Name/Device
Common
Name | Orthodontic Plastic Bracket | Orthodontic Plastic Bracket |
| Product
Code | NXC | NXC |
| Classification | II | II |
| Indications
for use | Park Dental Research Aligners are
indicated for the treatment of tooth
malocclusion in patients with
permanent dentition (i.e. all second
molars). Park Dental Research Aligners
positions 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 ClearCorrect System
positions teeth by way of continuous
gentle force. |
| Mode of
action | 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. |
| Material | Zendura polyurethane | Zendura polyurethane |
Conclusion:
Based on technological characteristics, mechanism of action, materials, indications for use and the results of non-clinical performance testing, Park Dental Research Aligners are substantially equivalent to ClearCorrect K113618.
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K180648
Device Name Park Dental Research Aligners
Indications for Use (Describe)
Park Dental Research Aligners are indicated for the treatment of tooth malocclusion in patients with permanent dentition (i.e. all second molars). Park Dental Research Aligners positions 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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Park Dental Research Corporation % Angela Blackwell Senior Consultant Blackwell Device Consulting P.O. Box 718 Gresham, Oregon 97030-0172
January 8, 2019
Re: K180648
Trade/Device Name: Park Dental Research Aligners Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: Class II Product Code: NXC Dated: November 29, 2018 Received: December 10, 2018
Dear Angela Blackwell:
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 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
5
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Digitally signed by Mary S. Mary S. Runner -S3 Runner -S3 Date: 2019.01.08
forTina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure