K Number

Device Name

MTM(R) CLEAR ALIGNER

Manufacturer

DENTSPLY INTERNATIONAL, INC.

Date Cleared

2013-10-11

(92 days)

Product Code

NXC

Regulation Number

872.5470

Intended 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 (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.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K123925

Reference Devices

K062828

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a system of physical aligners and standard dental software for image processing, with no mention of AI or ML.

Therapeutic

Yes
The device is indicated for the treatment of malocclusions and applies forces to achieve tooth movement, which constitutes a therapeutic effect.

Diagnostic

Explanation: The device, MTM® Clear-Aligner, is an orthodontic appliance used for tooth movement (treatment), not for diagnosing medical conditions. It aids in repositioning teeth based on a pre-existing diagnosis.

SaMD (Software as a Medical Device)

The device description explicitly states that the device is a "system of plastic aligners fabricated in an orthodontic appliance laboratory," which are physical objects. While software is used in the process (creating digital images and 3D overlays), the device itself is a physical product.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
Device Function: The MTM® Clear-Aligner is a physical appliance used to apply force to teeth for orthodontic treatment. It directly interacts with the patient's teeth and mouth.
Intended Use: The intended use is to treat anterior tooth malocclusions by physically moving teeth. This is a therapeutic intervention, not a diagnostic test performed on a specimen.
Device Description: The description details the fabrication and function of plastic aligners that apply force to teeth.
Lack of Specimen Analysis: There is no mention of analyzing any biological specimens from the patient. The "image processing" mentioned is for creating digital models of the teeth, not for analyzing biological samples.

Therefore, the MTM® Clear-Aligner falls under the category of a therapeutic medical device, not an In Vitro Diagnostic.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Product codes

NXC

Device Description

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

anterior tooth

Indicated Patient Age Range

Not Found

Intended User / Care Setting

dental practitioner / Orthodontic appliance laboratory, in-office

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 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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K123925

Reference Device(s)

K062828

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.

Summary

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) | Clearance
Date | Product
Code | Company Name |
|----------------------------------|---------|-------------------|-----------------|---------------------------|
| MTM® Clear Aligner In-
Office | K123925 | May 30, 2013 | NXC | DENTSPLY
International |

872.5470

4. Description of Device:

5. Indications for Use:

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.

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
Indication
Statement	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.	MTM® Clear Aligner In-Office 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.
Material	Thermoformed co-polyester or co-
polymer	Thermoformed co-polyester or co-
polymer
Method of
Application and
Removal	The aligners can be removed and
reinstalled by the patient for eating
and cleaning.	The aligners can be removed and
reinstalled by the patient for eating and
cleaning.
Duration of Use	Aligners are most effective if worn 20
to 22 hours per day - and removed
only for eating, brushing, and flossing.
Each aligner is worn for about 2-3
weeks before being replaced by the
next aligner in the sequence, until the
final position of the patient's teeth is
achieved.	Aligners are most effective if worn 20
to 22 hours per day -- and removed only
for eating, brushing, and flossing. Each
aligner is worn for about 2-3 weeks
before being replaced by the next
aligner in the sequence, until the final
position of the patient's teeth is
achieved.
Mechanism of
Action	MTM® Clear Aligner incorporates the
use of force points in order to exert
force on the teeth while the aligner is
being worn. This continuous force
moves teeth from their original to final
aligned position.	MTM® Clear Aligner In-Office
incorporates the use of force points in
order to exert force on the teeth while
the aligner is being worn. This
continuous force moves teeth from
their original to final aligned position.
Software	Commercially available dental
software is used to assist in the
manufacture of the aligners.	Software is not utilized in the device or
during the fabrication in the dental
office.
OTC or Rx	Rx	Rx

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.

Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

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.

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

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