Smart Moves Complete

K172765 · Great Lakes Orthodontics, Ltd. · NXC · Jun 1, 2018 · Dental

Device Facts

• Record ID: K172765
• Device Name: Smart Moves Complete
• Applicant: Great Lakes Orthodontics, Ltd.
• Product Code: NXC · Dental
• Decision Date: Jun 1, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.5470
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Smart Moves Complete is indicated for the treatment of tooth malocclusion in patients with permanent dentition (i.e. all second molars). Smart Moves Complete positions teeth by way of continuous gentle force.

Device Story

System consists of series of custom-fabricated, clear, thermoformed plastic aligners; intended as alternative to traditional brackets/wires. Dentist/orthodontist takes PVS impressions or digital scans; data sent to lab. Software generates 3D model of final treated state and intermediate stages. Prescribing physician reviews/approves treatment plan via software. Lab fabricates aligners using thermoforming. Patient wears aligners sequentially (2 weeks per stage), removing only for eating/brushing. Continuous gentle force moves teeth to programmed positions. Device is prescription-only; used in dental clinic/home settings. Benefits include virtually invisible appliance and avoidance of fixed braces.

Clinical Evidence

No clinical testing performed. Substantial equivalence supported by non-clinical bench testing, including biocompatibility (ISO 10993-1), software verification/validation, and mechanical property analysis (tensile strength, elongation, stress, modulus, load, water absorption, and durometer).

Technological Characteristics

Material: 0.03" Thermoplastic PETG. Sensing/Actuation: Passive mechanical force via thermoformed plastic. Form factor: Patient-specific removable aligners. Connectivity: Electronic submission of digital scans/prescriptions. Software: Dental tooth alignment design software. Biocompatibility: ISO 10993-1 compliant. Hardness: 80 ± 3 Shore D.

Indications for Use

Indicated for treatment of tooth malocclusion in patients with permanent dentition (all second molars).

Regulatory Classification

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.

Predicate Devices

• ClearCorrect System (K113618)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Great Lakes Orthodontics Ltd Mr. David Graver Director of Logistics 200 Cooper Ave Tonawanda, New York 14150

#### Re: K172765

Trade/Device Name: Smart Moves Complete Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: Class II Product Code: NXC Dated: April 30, 2018 Received: May 2, 2018

Dear David Graver:

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 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.

June1, 2018

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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.

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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Mary S. Runner -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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# Indications for Use

510(k) Number (if known) K172765

Device Name Smart Moves Complete

Indications for Use (Describe)

Smart Moves Complete is indicated for the treatment of tooth malocclusion in patients with permanent dentition (1.e. all second molars). Smart Moves Complete positions teeth by way of continuous gentle force.

Type of Use (Select one or both, as applicable)X Prescription Use (Part 21 CFR 801 Subpart D)

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

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## 510(k) Summary

#### Smart Moves Complete

#### K172675

## Sponsor

Great Lakes Orthodontics Ltd

200 Cooper Ave.

Tonawanda, NY 14150

Contact person:

Dave Graver

Director of Logistics

## Date Prepared: May 31, 2018

# Device Identification

Trade/Proprietary name: Smart Moves Complete Regulation Number: 21CFR 872.5470 Regulation Name: Aligner Sequential/ Orthodontic Plastic Bracket

Panel: Dental

Product Class: II

Product Code: NXC

#### Legally Marketed Predicate Device

K113618, ClearCorrect System, ClearCorrect Inc.

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## Indications for Use

Smart Moves Complete is indicated for the treatment of tooth malocclusion in patients with permanent dentition (i.e. all second molars). Smart Moves Complete positions teeth by way of continuous gentle force.

#### Background

Orthodontic treatment is conventionally performed using brackets and archwires. A bracket is bonded to each tooth and a wire is inserted with the goal of moving each tooth to a desired final treatment position. An alternative to traditional bracket treatment has been in existence for the past 20 years. This alternative treatment uses clear plastic aligners to gradually move the teeth. The aligners are designed in a series of incremental stages. A patient wears each aligner stage for a period of two weeks to accomplish the programmed tooth movement. Once tooth movement has been accomplished for a given stage the current aligner is removed and the next aligner in the sequence is worn. This method of orthodontic treatment is popular with patients because it provides a virtually invisible appliance and avoids the appearance of braces on the teeth.

#### Design and Use

- This is a prescription use device by order of a Dentist or Orthodontist ●
- Designed for single patient use (2 weeks/aligner)
- Aligners are worn except for eating and brushing teeth. They are removed by the patient for those tasks.
- It is not provide sterile
- It does not contain any drugs or biologic
- Software as part of the system is used by the Dental lab to design the aligners that the ● Dental professional reviews and approves prior to fabrication.
- No clinical studies are included in the submission

## Device Description

## Aligner System

A dental health professional (e.g. orthodontist or dentist) prescribes Smart Moves Complete based on an assessment of the patient's teeth, takes molds of the patient's teeth, determines a course of treatment to reposition the teeth via gentle, corrective forces in the upper and lower dental arch, and completes a prescription form. Digital information concerning the patient's teeth and the prescription form are then sent electronically to Great Lakes Orthodontics.

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Great Lakes then designs a series of plastic thermoformed aligners in a sequential series intended to gradually realign the patient's teeth in accordance with the physician's prescription using standard dental tooth alignment software. The prescribing physician accesses the doctor-facing portion of the standard dental tooth alignment software to review and approve the model scheme before the thermoformed aligners are produced. Once approved, Great Lakes Orthodontics produces these aligners, which are formed of clear, thin, thermoformed plastic.

The aligners in a sequential series are sent back to the dental health care professional who then provides them to the patient, confirming fit and design. Over a period of time, each progression of aligners are provided sequentially to the patient by the dental health professional to gradually move the target teeth to the designed position. The dental care professional monitors treatment from the moment the first aligner is delivered to when the final aligner is delivered. The aligners are held in place by pressure and can be removed by the patient at any time.

| Manufacturer | Great Lakes<br>Orthodontics, Ltd. | ClearCorrect Inc. | Device Comparison |
|------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name | Smart Moves Complete | ClearCorrect System | N/A |
| 510(k) Number | K172765 | K113618 | N/A |
| Product Code | NXC | NXC | Same |
| Regulation Number | 872.5470 | 872.5470 | Same |
| Regulation Name | Orthodontic Plastic<br>Bracket | Orthodontic Plastic<br>Bracket | Same |
| Indications for Use<br>Statement | Smart Moves Complete is<br>indicated for the<br>treatment of tooth<br>malocclusion in patients<br>with permanent<br>dentition (i.e. all second<br>molars). Smart Moves<br>Complete positions teeth<br>by way of continuous<br>gentle force. | The ClearCorrect System<br>is indicated for the<br>treatment of tooth<br>malocclusion in patients<br>with permanent<br>dentition (i.e. all second<br>molars). The<br>ClearCorrect System<br>positions teeth by way of<br>continuous gentle force. | Same |
| Device Description | Smart Moves Complete<br>consists of a series of<br>doctor-prescribed, thin,<br>clear plastic removable<br>orthodontic appliances<br>(aligners). The aligners<br>gently move the patient's<br>teeth in small increments<br>from their original state<br>to a more optimal,<br>treated state. Smart<br>Moves Complete is<br>intended as an<br>alternative to | The ClearCorrect device<br>is fabricated of clear thin<br>thermoformed<br>polyurethane plastic in a<br>sequential series to<br>progressively reposition<br>the teeth. Corrective<br>force to straighten the<br>teeth is delivered via<br>minor changes into a<br>position in each<br>subsequent aligner. | Same; the device<br>performs treatment of<br>tooth malocclusions in<br>the same way by<br>continuous gentle force. |
| | | | |
| | conventional bracket<br>technology and fixed<br>appliances for the<br>treatment of patients<br>with malocclusion. | | |
| Mode of Action | Orthodontic tooth<br>movement occurs<br>through forces applied by<br>the appliance to the<br>dentition as each tooth<br>follows the programmed<br>displacement based on a<br>doctor's prescription. | Orthodontic tooth<br>movement occurs<br>through forces applied by<br>the appliance to the<br>dentition as each tooth<br>follows the programmed<br>displacement based on a<br>doctor's prescription. | Same |
| Anatomy Location | Mouth; mucosal<br>membranes | Mouth; mucosal<br>membranes | Same |
| Size | Patient specific | Patient specific | Same |
| Manufacturing Method | Thermoforming | Thermoforming | Same |
| Material | 0.03" Thermoplastic<br>PETG | 0.03" Thermoplastic<br>Polyurethane | Similar; these are both<br>thermoplastic forming<br>materials that have same<br>durometer, similar<br>properties in modulus<br>that do not raise any<br>additional questions of<br>safety or efficacy. |
| Biocompatibility | Passed ISO 10993-1 and<br>series | Passed ISO 10993-1 and<br>series | Same |
| Hardness Durometer | $80 \pm 3$ Shore D | $80 \pm 3$ Shore D | Same |
| Material Tensile<br>Strength/Stress | Strength and stress of<br>material tensile<br>produced acceptable<br>results for base material | Information not available | Base materials of<br>thermoplastic used to<br>fabricate aligners uses<br>similar material used in<br>these applications gentle<br>tooth alignment. The<br>materials are<br>thermoformed plastics<br>that are similar in<br>composition to the<br>predicate device not<br>raising any additional<br>questions of safety or<br>efficacy. |
| Material Elongation | Elongation at yield and<br>break produced<br>acceptable results for<br>base material | Information not available | Base materials of<br>thermoplastic used to<br>fabricate aligners uses<br>similar material used in<br>these applications gentle<br>tooth alignment. The<br>materials are<br>thermoformed plastics<br>that are similar in<br>composition to the<br>predicate device not<br>raising any additional |
| | | | |
| Material Modulus | Modulus results<br>produced similar results<br>for testing of base<br>material | Information not available | Base materials of<br>thermoplastic used to<br>fabricate aligners uses<br>similar material used in<br>these applications gentle<br>tooth alignment. The<br>materials are<br>thermoformed plastics<br>that are similar in<br>composition to the<br>predicate device not<br>raising any additional<br>questions of safety or<br>efficacy. |
| Material Load | Load at yield and break<br>produced acceptable<br>results for base material | Information not available | Base materials of<br>thermoplastic used to<br>fabricate aligners uses<br>similar material used in<br>these applications gentle<br>tooth alignment. The<br>materials are<br>thermoformed plastics<br>that are similar in<br>composition to the<br>predicate device not<br>raising any additional<br>questions of safety or<br>efficacy. |
| Dental Tooth Alignment<br>Software Description | The Smart Moves<br>Complete 3-D software<br>uses a scan of a PVS<br>impression or a digital<br>scan to generate the<br>image of a final, treated<br>state and then interprets<br>a series of images that<br>represent intermediate<br>teeth states. Once the<br>dental practitioner<br>approves the treatment<br>plan, the software<br>converts the files to<br>produce the series of<br>patient specific aligners. | The standard dental<br>tooth alignment software<br>uses a scan of tooth<br>impression or a digital<br>scan to generate the<br>image of a final, treated<br>state and then interprets<br>a series of images that<br>represent intermediate<br>teeth states. Once the<br>dental practitioner<br>approves the treatment<br>plan, the software<br>converts the files to<br>produce the series of<br>patient specific aligners. | Same |
| Healthcare Professional<br>Review | The dental practitioner<br>reviews final aligner<br>series prior to fabrication<br>and has the option to<br>reject or request<br>modifications to the set-<br>up prior to approving it<br>for aligner fabrication. | The dental practitioner<br>reviews final aligner<br>series prior to fabrication<br>and has the option to<br>reject or request<br>modifications to the set-<br>up prior to approving it<br>for aligner fabrication. | Same |

#### Predicate Device Comparison

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#### Non-Clinical Performance Testing

As part of demonstrating safety and effectiveness of Smart Moves Complete and in showing substantial equivalence to the predicate devices that are subject to this 510(k) submission, Great Lakes Orthodontics completed a number of non-clinical performance tests. The Smart Moves Complete 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 Smart Moves Complete passed all the testing in accordance with internal requirements, national standards, and international standards shown below to support substantial equivalence of the subject device:

- Biocompatibility testing per ISO 10993-1 passed cytotoxicity, sensitization, and irritation .
- Software verification and validation testing using FDA's guidance document confirmed . acceptance to required specifications
- There is no defined specification or standard for tensile strength so a sample of base . materials used for fabrication of aligners were tested and analyzed producing acceptable results for tensile strength yield
- . There is no defined specification or standard for aligner elongation which a sample of based materials used for fabrication of aligners were tested and analyzed showing acceptable results in comparison of break point
- . There is no defined specification or standard for tensile stress so a sample of base materials used for fabrication of aligners were tested and analyzed producing acceptable results for tensile stress at break point
- . There is no defined specification or standard for modulus so this was tested for the base materials used for fabrication of aligners to show acceptable results between the samples tested
- There is no defined specification or standard for load of materials which found acceptable ● results when tested and analyzed for samples of base material tested used for fabrication of aligners
- There is no defined specification or standard for water absorption which found acceptable ● results when tested and analyzed for fabricated aligners
- Durometer testing of thermoplastic forming material 80 ± 3 Shore D: Acceptable .

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- Process Flow validation was performed to ensure that the finished device matches the software output specifications. The output and work model and aligner were tested and compared. Aligners met the specifications of this testing.
#### Clinical Performance Data

There was no clinical testing performed to support the medical device as the indications for use is equivalent to the predicate device. The substantial equivalence is supported by non-clinical testing and the comparative table, so this is not required.

#### 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 Smart Moves Complete is determined to be substantially equivalent to the referenced predicate device(s).