(85 days)
No
The summary does not mention any AI or ML technology, focusing instead on the mechanical action of the clear aligners and referencing previous submissions and literature reviews.
Yes
The device is indicated for the treatment of anterior tooth malocclusions, which is a therapeutic purpose.
No
The device description indicates it is a therapeutic device used for tooth movement, not for diagnosing medical conditions.
No
The device description explicitly states that the device consists of "custom made removable plastic orthodontic appliances," which are physical hardware components.
Based on the provided information, the MTM® Clear Aligner is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for the treatment of anterior tooth malocclusions. This is a therapeutic purpose, not a diagnostic one. IVD devices are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The device is described as a series of custom-made removable plastic orthodontic appliances that position teeth. This is a physical device used for treatment, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), performing tests on specimens, or providing diagnostic information.
Therefore, the MTM® Clear Aligner falls under the category of a therapeutic medical device, specifically an orthodontic appliance, rather than an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
MTM® Clear Aligner is indicated for the treatment of anterior tooth malocclusions in patients with permanent dentition (i.e. all second molars). Utilizing a series of incremental minor tooth movements, MTM® Clear Aligner sequentially positions teeth by way of continuous gentle force.
Product codes
NXC
Device Description
MTM® Clear Aligner consists of a series of custom made removable plastic orthodontic appliances that sequentially positions teeth by way of continuous gentle force.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
anterior tooth (in patients with permanent dentition)
Indicated Patient Age Range
Not Found
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
No additional non-clinical bench testing has been included in this submission. Nonclinical data was previously submitted and reviewed to support clearance of the primary predicate MTM® Clear Aligner under premarket notification K132145.
No new human clinical data has been included in this submission: however a literature review was conducted. Clinical data was previously submitted and reviewed to support clearance of the primary predicate MTM® Clear Aligner under premarket notification K132145, as well as in a prior submission for the MTM® Clear Aligner In-Office system under premarket notification K123925. This data demonstrated performance of the predicate MTM® Clear Aligner for sequential minor incremental tooth movements using Raintree Essix plastics with force point technology. A literature review was conducted in support of the proposed device modification. The literature review is included in this submission to provide valid scientific evidence for intrusive and extrusive orthodontic tooth movements achieved with clear aligner therapy.
Key Metrics
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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling a symbol. The symbol is a stylized representation of three human profiles facing right, stacked on top of each other. The profiles are rendered in a dark color, contrasting with the white background.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 3, 2017
Dentsply Sirona Ms. Helen Lewis Director Corporate Regulatory Affairs 221 West Philadelphia Street Suite 60 York, Pennsylvania 17408
Re: K163155
Trade/Device Name: MTM Clear Aligner Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: Class II Product Code: NXC Dated: November 9, 2016 Received: November 10, 2016
Dear Helen Lewis:
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. 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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely.
Michael J. Ryan -S
for Tina 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
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known)
Device Name
MTM® Clear Aligner
Indications for Use (Describe)
MTM® Clear Aligner is indicated for the treatment of anterior tooth malocclusions in patients with permanent dentition (i.e. all second molars). Utilizing a series of incremental minor tooth movements, MTM® Clear Aligner sequentially 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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Dentsply Sirona 221 West Philadelphia Street Suite 60 York, PA 17404
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510(k) SUMMARY for MTM® Clear Aligner (K163155)
Submitter Information: 1.
Dentsply Sirona 221 West Philadelphia Street Suite 60 York, PA 17404
| Contact Person: | Helen Lewis |
|---|---|
| Telephone Number: | 717-487-1332 |
| Fax Number: | 717-849-4343 |
Date Prepared: 19 January 2017
2. Device Name:
- MTM® Clear Aligner Proprietary Name: ●
- Classification Name: Aligner, Sequential ●
- CFR Number: 872.5470 ●
- Device Class: . II
- Product Code: NXC ●
3. Predicate Devices:
| Predicate Device Name | 510(k) | Company Name |
|---|---|---|
| MTM® Clear Aligner | K132145 | Raintree Essix Inc. |
| ClearPath Aligner | K123514 | ClearPath Orthodontics |
4. Description of Device:
MTM® Clear Aligner consists of a series of custom made removable plastic orthodontic appliances that sequentially positions teeth by way of continuous gentle force.
న. Indications for Use:
MTM® Clear Aligner is indicated for the treatment of anterior tooth malocclusions in patients with permanent dentition (i.e. all second molars). Utilizing a series of incremental minor tooth movements, MTM® Clear Aligner sequentially positions teeth by way of continuous gentle force.
Indications for Use Comparison:
In this submission we focus on removing mention of specific movement types from the indications for use statement of the primary predicate. The indications for use are similar between the primary predicate MTM® Clear Aligner and the proposed MTM® Clear Aligner with expanded indications. Both devices are indicated for the correction of anterior tooth misalignments (malocclusions) in
4
patients with permanent teeth, using a series of aligners. The primary predicate specifies that four types of tooth movement are used, whereas the proposed MTM® Clear Aligner removes the specific tooth movement types from the indications for use statement, to allow all types of tooth movement to be used.
The indications for use are fundamentally the same between the reference predicate, ClearPath Aligner and the proposed MTM® Clear Aligner. Both devices are indicated for the correction of anterior tooth misalignments (malocclusions) in patients with permanent teeth, using a series of aligners. Neither of them specify the types of tooth movement to be used.
The change in the indications for use to remove specific tooth movement types for the proposed MTM® Clear Aligner does not result in a new intended use for the current, primary predicate MTM® Clear Aligner. This change does not raise new concerns as evidenced in the scientific literature reviewed.
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6. Substantial Equivalence:
Table 5.1 Device Comparison Table
| Element | Proposed Device | Primary Predicate | Reference Predicate | Comparison |
|---|---|---|---|---|
| 510(k) | K163155 | K132145 | K123514 | N/A |
| Device Name | MTM® Clear Aligner | MTM® Clear Aligner | ClearPath Aligner | N/A |
| Manufacturer | Raintree Essix Inc. | Raintree Essix Inc. | ClearPath Orthodontics | N/A |
| Intended Use | Treatment of anterior tooth | |||
| malocclusions in patients with | ||||
| permanent dentition | Treatment of anterior tooth | |||
| malocclusions in patients with | ||||
| permanent dentition | Correction of dental malocclusion | |||
| in patients with permanent | ||||
| dentition | Same | |||
| Indications for | ||||
| Use | MTM® Clear Aligner is indicated | |||
| for the treatment of anterior tooth | ||||
| malocclusions in patients with | ||||
| permanent dentition (i.e. all second | ||||
| molars). Utilizing a series of | ||||
| incremental minor tooth | ||||
| movements, MTM® Clear Aligner | ||||
| sequentially positions teeth by way | ||||
| of continuous gentle force. | MTM® Clear Aligner is indicated for | |||
| the treatment of anterior tooth | ||||
| malocclusions in patients with | ||||
| permanent dentition (i.e. all second | ||||
| molars). Utilizing a series of | ||||
| incremental minor tooth movements | ||||
| (torque, tipping, rotation and bodily | ||||
| movement), MTM® Clear Aligner | ||||
| sequentially positions teeth by way of | ||||
| continuous gentle force. | The ClearPath Aligner is a series | |||
| of clear, lightweight, plastic | ||||
| appliances indicated for the | ||||
| correction of dental malocclusion | ||||
| in patients with permanent | ||||
| dentition (i.e. all second molars). | ||||
| The ClearPath Aligner is intended | ||||
| for minor anterior tooth movement | ||||
| by way of continuous gentle force. | Same as reference | |||
| predicate. Removing | ||||
| specific movement types | ||||
| from primary predicate | ||||
| IFU statement. | ||||
| Tooth | ||||
| Movement | ||||
| Types | All | All except intrusion and extrusion. | All | Same as reference |
| predicate. Removing | ||||
| specific movement types | ||||
| from primary predicate | ||||
| IFU statement to allow | ||||
| for intrusive and extrusive | ||||
| movements. | ||||
| Material | Co-polyester or Co-polymer | Co-polyester or Co-polymer | Co-Polyester | Same |
| Mode of | ||||
| Action | Continuous gentle force applied to | |||
| teeth to achieve movement. | Continuous gentle force applied to teeth | |||
| to achieve movement. | Continuous gentle force applied to | |||
| teeth to achieve movement. | Same | |||
| Features | Sequential thermoformed plastic | |||
| aligners used in the alignment of | ||||
| teeth by application of continuous | ||||
| gentle force. Aligners can be | ||||
| removed by the patient for eating | ||||
| and cleaning. Aligners are most | ||||
| effective when worn 20-22 hours | ||||
| per day. | Sequential thermoformed plastic | |||
| aligners used in the alignment of teeth | ||||
| by application of continuous gentle | ||||
| force. Aligners can be removed by the | ||||
| patient for eating and cleaning. Aligners | ||||
| are most effective when worn 20-22 | ||||
| hours per day. | Sequential thermoformed plastic | |||
| aligners used in the alignment of | ||||
| teeth by application of continuous | ||||
| gentle force. Aligners can be | ||||
| removed by the patient for eating | ||||
| and cleaning. Aligners are most | ||||
| effective when worn 20-22 hours | ||||
| per day. | Same |
The technological characteristics of the proposed MTM® Clear Aligner are unchanged from those of the primary predicate MTM® Clear Aligner device cleared under premarket notification K132145.
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7. Non-Clinical Performance Data
No additional non-clinical bench testing has been included in this submission. Nonclinical data was previously submitted and reviewed to support clearance of the primary predicate MTM® Clear Aligner under premarket notification K132145.
8. Clinical Performance Data
No new human clinical data has been included in this submission: however a literature review was conducted. Clinical data was previously submitted and reviewed to support clearance of the primary predicate MTM® Clear Aligner under premarket notification K132145, as well as in a prior submission for the MTM® Clear Aligner In-Office system under premarket notification K123925. This data demonstrated performance of the predicate MTM® Clear Aligner for sequential minor incremental tooth movements using Raintree Essix plastics with force point technology. A literature review was conducted in support of the proposed device modification. The literature review is included in this submission to provide valid scientific evidence for intrusive and extrusive orthodontic tooth movements achieved with clear aligner therapy.
9. Conclusion Regarding Substantial Equivalence
The data submitted for non-clinical and clinical performance testing, as well as the technological characteristics of the proposed MTM® Clear Aligner device support substantial equivalence when compared to the predicate devices.