NemoCast

K193003 · Software Nemotec S.L. · PNN · Jun 5, 2020 · Dental

Device Facts

• Record ID: K193003
• Device Name: NemoCast
• Applicant: Software Nemotec S.L.
• Product Code: PNN · Dental
• Decision Date: Jun 5, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.5470
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

NemoCast is intended for supporting the diagnostic and treatment plan processes for orthodontic procedures related to minor anterior tooth movements; it provides tools for management of orthodontic models, systemic inspection, detailed analysis, treatment simulation and virtual appliance design options (export of models) based on 3D models of the patient's dentition before the start of an orthodonic treatment. It can also be applied to evaluate if the outcome is consistent with the planned/desired treatment objectives. NemoCast requires the user to have the necessary training and domain knowledge in the practice of orthodontics, as well as to have received a dedicated training in the use of the software.

Device Story

NemoCast is a software-based orthodontic planning tool; inputs 3D dental models (scans) of patient dentition. Software provides tools for model management, inspection, analysis, treatment simulation, and virtual appliance design. Used by orthodontists in clinical settings to plan minor anterior tooth movements and evaluate treatment outcomes against objectives. Output consists of virtual models and treatment simulations to assist clinical decision-making; facilitates design of orthodontic appliances. Benefits include improved visualization and planning accuracy for orthodontic procedures.

Clinical Evidence

No clinical data provided; device is software for orthodontic planning and simulation.

Technological Characteristics

Software-based orthodontic planning system; operates on standard computing hardware; provides 3D visualization, measurement, and simulation tools for dental models; supports export of virtual appliance designs.

Indications for Use

Indicated for orthodontic patients requiring minor anterior tooth movements. Requires clinician with orthodontic training and specific software training.

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.

Submission Summary (Full Text)

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June 5, 2020

Software Nemotec S.L. % Kevin Walls Principal Consultant Regulatory Insight, Inc. 33 Golden Eagle Lane Littleton, Colorado 80127

Re: K193003

Trade/Device Name: NemoCast Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: Class II Product Code: PNN, LZZ Dated: April 30, 2020 Received: May 5, 2020

Dear Kevin Walls:

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

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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 devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

for Srinivas "Nandu" Nandkumar, Ph.D. Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K193003

Device Name NemoCast

Indications for Use (Describe)

NemoCast is intended for supporting the diagnostic and treatment plan processes for orthodontic procedures related to minor anterior tooth movements; it provides tools for management of orthodontic models, systemic inspection, detailed analysis, treatment simulation and virtual appliance design options (export of models) based on 3D models of the patient's dentition before the start of an orthodonic treatment. It can also be applied to evaluate if the outcome is consistent with the planned/desired treatment objectives.

NemoCast requires the user to have the necessary training and domain knowledge in the practice of orthodontics, as well as to have received a dedicated training in the use of the software.

| 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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