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.

Device Description

MTM® Clear-Aligner is a system of plastic aligners fabricated in an orthodontic appliance laboratory. The formed aligners contain force points and spaces necessary for tooth movement by way of continuous gentle force. As the aligner is positioned on any particular tooth, the presence of the force points loads the polymeric shell material. The stored energy thus imparted into the elastomeric material of the aligner slowly dissipates over time as the bone underlying the tooth physiologically responds to the forces. After the entire series of aligners are produced by the MTM® Service Center for the prescribed case, they are shipped to the dental practitioner. Each individual aligner moves the patient's teeth in small increments from their original state to a final state.

AI/ML Overview

This submission for the MTM® Clear-Aligner is a 510(k) premarket notification, which demonstrates substantial equivalence to a predicate device rather than providing extensive clinical study data to meet specific acceptance criteria for novel devices. Therefore, much of the requested information regarding clinical studies and detailed performance metrics (like effect sizes for MRMC studies, standalone performance with AI, sample sizes for training/test sets, and expert details for ground truth) is not applicable or not provided in this type of submission.

The core of this submission revolves around demonstrating that the new device (MTM® Clear-Aligner) is substantially equivalent to a previously cleared predicate device (MTM® Clear Aligner In-Office). The acceptance criterion here is "substantial equivalence" based on technological characteristics, indications for use, and safety/performance.

Here's the breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a substantial equivalence submission, the "acceptance criteria" are effectively the characteristics of the predicate device that the new device must match or be demonstrably as safe and effective as. The "reported device performance" is a comparison to those characteristics.

Acceptance Criteria (Predicate Device K123925)	Reported Device Performance (MTM® Clear-Aligner)
Product Code: NXC	Product Code: NXC
Indication Statement: Treatment of anterior tooth malocclusions in patients with permanent dentition, using incremental minor tooth movements (torque, tipping, rotation, bodily movement) to sequentially position teeth via continuous gentle force.	Indication Statement: Identical to predicate device.
Material: Thermoformed co-polyester or co-polymer	Material: Identical to predicate device.
Method of Application/Removal: Removable by patient for eating and cleaning.	Method of Application/Removal: Identical to predicate device.
Duration of Use: Worn 20-22 hours/day, removed only for eating, brushing, flossing. Each aligner worn 2-3 weeks.	Duration of Use: Identical to predicate device.
Mechanism of Action: Incorporates force points to exert continuous force for tooth movement.	Mechanism of Action: Identical to predicate device.
Software: Not utilized in predicate device or during fabrication in dental office.	Software: Commercially available dental software used to assist in manufacture of aligners. (This is a difference handled by performance qualification of the software).
OTC or Rx: Rx	OTC or Rx: Rx

Device Performance Claim: The MTM® Clear-Aligner is substantially equivalent to the predicate device because it shares the same indications for use, intended use, fundamental technological characteristics, and materials. The use of commercially available software is addressed by "performance qualification" of that software.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not applicable. No dedicated 'test set' in the context of a new clinical study is described for this 510(k) submission.
Data Provenance: The submission relies on "All non-clinical performance data was included in the predicate submission, premarket notification K123925." A "clinical evaluation was performed utilizing the predicate device MTM® Clear Aligner In-Office cleared under K123925" which collected safety and performance data. This data would be retrospective relative to this current application but was originally prospective for the predicate device. No new human clinical data was included in this submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

Not applicable. There is no new clinical study with a test set requiring expert-established ground truth for this submission. The submission references data from the predicate device's clinical evaluation.

4. Adjudication Method

Not applicable. No new clinical study requiring adjudication is mentioned.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. An MRMC comparative effectiveness study was not done for this submission. The submission explicitly states "No new human clinical data has been included in this premarket notification." The study focuses on demonstrating substantial equivalence, not comparative effectiveness of human readers with/without AI assistance.

6. Standalone Performance (Algorithm only without human-in-the-loop performance)

Not directly applicable in the terms of typical AI/ML algorithm evaluation. The device involves the use of "commercially available dental software to create digital images and 3D overlays of the patient's dentition." A "performance qualification of the commercially available software utilized in the processing steps of the subject MTM® Clear-Aligner has been included to support substantial equivalence." This "performance qualification" would be the closest analogue to a standalone performance evaluation, but specifics of that qualification (metrics, data, etc.) are not provided in this document as it refers to a software component rather than the device as a whole.

7. Type of Ground Truth Used

For the performance data referenced from the predicate device, it's implied that the "safety and performance data regarding DENTSPLY aligner materials and force points to demonstrate the ability of the MTM® Clear-Aligner technology to achieve sequential incremental minor tooth movement" would be based on clinical outcomes (e.g., actual tooth movement, patient comfort, treatment success rates as assessed by dental practitioners). However, the details are not provided in this document.

8. Sample Size for the Training Set

Not applicable. This submission does not describe the development or training of a new AI/ML model for which a training set would be used. The software mentioned is "commercially available dental software" which likely means a pre-existing package not developed by DENTSPLY for this specific submission, and its internal training data is not part of this document.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there's no description of a training set for a new AI/ML model in this submission.

Summary

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K132145

1. Submitter Information:

DENTSPLY International Susquehanna Commerce Center 221 West Philadelphia Street York. PA 17405

Contact Person:	Helen Lewis
Telephone Number:	717-487-1332
Fax Number:	717-849-4343

Date Prepared: June 6, 2013

OCT 1 1 2013

2. Device Name:

Proprietary Name: MTM® Clear. Aligner . Aligner, Sequential
Classification Name: .
CFR Number: .
Device Class: .
Product Code: NXC .
Predicate Device: 3.

Product Name	510(K)	ClearanceDate	ProductCode	Company Name
MTM® Clear Aligner In-Office	K123925	May 30, 2013	NXC	DENTSPLYInternational

872.5470

4. Description of Device:

5. Indications for Use:

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Description of Safety and Substantial Equivalence: 6.

Technological Characteristics:

MTM® Clear-Aligner has the same technological characteristics as the predicate device MTM® Clear Aligner In-Office in that a series of aligners are made by thermoforming commercially available DENTSPLY plastics. The series of aligners are then used to sequentially position teeth by way of continuous gentle force.

In both systems, the same DENTSPLY commercially available aligner materials are used. These plastics were originally cleared under K062828 (Mouthguard and Aligners materials). The MTM® Clear-Aligners are thermoformed by the MTM® Service Center (Orthodontic Laboratory) whereas the predicate MTM® Clear Aligner In-Office devices are thermoformed by the healthcare practitioner in-office.

Within the process of the subject device, the clinician submits impressions of the patient's teeth as well as a prescription form to the MTM® Clear Aligner Service Center. The MTM® Service Center uses standard commercially available dental software to create digital images and 3D overlays of the patient's dentition. These files are sent to the clinician along with a treatment plan for approved by the clinician, the MTM® Service Center creates the aligners by thermoforming commercially available DENTSPLY plastics and sends them to the clinician. The clinician confirms the fit of the aligners upon delivery to the patient and monitors the patient's progress throughout treatment. In both systems, the healthcare practitioner is responsible for the treatment plan approval. Both systems utilize force points in order to cause minor tooth movement. The series of aligners created by both systems are used to sequentially position teeth by way of continuous gentle force and may be removed by the patient at any time.

Non-Clinical Performance Data:

The MTM® Clear+Aligner is composed of the identical, existing, commercially available DENTSPLY Aligner Materials used in the predicate device. All non-clinical performance data was included in the predicate submission, premarket notification K123925. No additional in vitro testing has been included to support the substantial equivalence of the MTM® Clear. Aligner.

A performance qualification of the commercially available software utilized in the processing steps of the subject MTM® Clear-Aligner has been included to support substantial equivalence.

Clinical Performance Data

A clinical evaluation was performed utilizing the predicate device MTM® Clear Aligner In-Office cleared under K123925 in order to collect safety and performance data regarding DENTSPLY aligner materials and force points to demonstrate the ability of the MTM® Clear-Aligner technology to achieve sequential incremental minor tooth movement (including torque, tipping, rotation and bodily translation), consistent with and fully supportive of the product's indications for use.

No new human clinical data has been included in this premarket notification to support the substantial equivalence of the MTM® Clear.Aligner.

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Conclusion as to Substantial Equivalence:

MTM® Clear-Aligner moves teeth by way of continuous gentle force using a series of clear aligners and force points that follow the treatment plan prescribed by the clinician as does the predicate device MTM® Clear Aligner In-Office. Table 5.1 summarizes the comparison of the subject MTM® Clear•Aligner with the predicate MTM® Clear Aligner In-Office cleared in K123925).

Table 5.1 Substantial Equivalence Chart
	NEW DEVICE	PREDICATE DEVICE
	MTM® Clear Aligner	MTM® Clear Aligner In-Office(K123925)
Product Code	NXC	NXC
IndicationStatement	MTM® Clear Aligner is indicated forthe treatment of anterior toothmalocclusions in patients withpermanent dentition (i.e. all secondmolars). Utilizing a series ofincremental minor tooth movements(torque, tipping, rotation and bodilymovement), MTM® Clear Alignersequentially positions teeth by way ofcontinuous gentle force.	MTM® Clear Aligner In-Office isindicated for the treatment of anteriortooth malocclusions in patients withpermanent dentition (i.e. all secondmolars). Utilizing a series ofincremental minor tooth movements(torque, tipping, rotation and bodilymovement), MTM® Clear Alignersequentially positions teeth by way ofcontinuous gentle force.
Material	Thermoformed co-polyester or co-polymer	Thermoformed co-polyester or co-polymer
Method ofApplication andRemoval	The aligners can be removed andreinstalled by the patient for eatingand cleaning.	The aligners can be removed andreinstalled by the patient for eating andcleaning.
Duration of Use	Aligners are most effective if worn 20to 22 hours per day - and removedonly for eating, brushing, and flossing.Each aligner is worn for about 2-3weeks before being replaced by thenext aligner in the sequence, until thefinal position of the patient's teeth isachieved.	Aligners are most effective if worn 20to 22 hours per day -- and removed onlyfor eating, brushing, and flossing. Eachaligner is worn for about 2-3 weeksbefore being replaced by the nextaligner in the sequence, until the finalposition of the patient's teeth isachieved.
Mechanism ofAction	MTM® Clear Aligner incorporates theuse of force points in order to exertforce on the teeth while the aligner isbeing worn. This continuous forcemoves teeth from their original to finalaligned position.	MTM® Clear Aligner In-Officeincorporates the use of force points inorder to exert force on the teeth whilethe aligner is being worn. Thiscontinuous force moves teeth fromtheir original to final aligned position.
Software	Commercially available dentalsoftware is used to assist in themanufacture of the aligners.	Software is not utilized in the device orduring the fabrication in the dentaloffice.
OTC or Rx	Rx	Rx

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MTM® Clear-Aligner is substantially equivalent to the predicate device MTM® Clear Aligner In-Office cleared under K123925 in that both systems have the same indications for use, same intended use, incorporate the same fundamental technological characteristics and they are composed of the same materials. Testing to demonstrate the acceptability of the commercially available software utilized in the treatment planning steps has been included to support substantial equivalence. Based on the similarities of the two devices, it is concluded that MTM® Clear+Aligner is substantially equivalent to the predicate device MTM® Clear Aligner In-Office.

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WORA-GoO Silver Spring, MD 20993-0002

October 11, 2013

Dentsply International, Incorporated Ms. Helen Lewis Director of Corporate Regulatory Affairs Susquehanna Commerce Center 221 West Philadelphia Street York, PA 17405

Re: K132145

Trade/Device Name: MTM® Clear.Aligner Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: II Product Code: NXC Dated: September 18, 2013 Received: September 18, 2013

Dear Ms. 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 for ase have in the 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.

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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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in 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 Small Manufacturers, International and Consumer Assistance at its tollfree 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" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Marys Runner -S

Kwame Ulmer M.S. Acting Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation . Center for Devices and Radiological Health

公

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SECTION 4: INDICATIONS FOR USE STATEMENT

KI32145 510(k) Number (if known):

Device Name: MTM® Clear-Aligner

Indications for Use:

Prescription Use _ X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Premarket Notification

Regulation Number and Section

§ 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.