Nuvola

K222418 · Gruppo Europeo Ortodonzia Srl · NXC · Oct 7, 2022 · Dental

Device Facts

• Record ID: K222418
• Device Name: Nuvola
• Applicant: Gruppo Europeo Ortodonzia Srl
• Product Code: NXC · Dental
• Decision Date: Oct 7, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.5470
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Indications for Use

Nuvola® aligner is intended for the orthodontic treatment of malocclusion

Device Story

Nuvola is a series of removable, custom-made thermoplastic (PET-G) aligners for orthodontic treatment. Clinicians obtain patient dental scans, which are uploaded to Nuvola®Web software. Using 3Shape Ortho System (K152086), the software generates 3D models of the patient's dentition and simulates tooth movements. The clinician reviews and approves the treatment plan. 3D printers create molds for each sequential treatment step; aligners are thermoformed over these molds. The clinician monitors the patient's progress as they wear each aligner for 1-2 weeks (20-22 hours/day). The device applies continuous gentle force to move teeth incrementally toward the desired final position. Used in clinics by dental practitioners to treat malocclusion in children, adolescents, and adults.

Clinical Evidence

No clinical studies were conducted. Substantial equivalence is supported by non-clinical bench testing, including manufacturing process validation (point-to-point and critical displacement measurements), biocompatibility testing per ISO 10993-1, 1-year real-time shelf-life aging, and ISTA 2A packaging integrity testing. Software validation was performed per IEC 62304.

Technological Characteristics

Sequential thermoformed aligners made of PET-G (Erkodur). Manufacturing involves 3D printing of molds followed by thermoforming. Software-driven treatment planning (Nuvola®Web) and 3D tooth movement simulation (3Shape Ortho System). Class II device, prescription use, non-sterile.

Indications for Use

Indicated for orthodontic treatment of malocclusion in patients with primary, mixed, and permanent dentition.

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

• Invisalign System (K220287)

Reference Devices

• Ortho Aligner System (K212496)
• 3Shape Ortho System (K152086)
• Invisalign System 3-D Software (K081960)
• Erkodur (K200125)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a sans-serif font.

October 7, 2022

Gruppo Europeo Ortodonzia srl % Carlo D`Alessandro Director, Quality and Regulatory Donawa Lifescience Consulting srl Piazza Albania. 10 Rome, 00153 ITALY

Re: K222418

Trade/Device Name: Nuvola Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: Class II Product Code: NXC Dated: August 5, 2022 Received: August 10, 2022

Dear Carlo D`Alessandro:

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.

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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 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 (QS) 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.

Michael E. Adjodha, M.ChE. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

### Indications for Use

510(k) Number (if known)

K222418

Device Name Nuvola®

Indications for Use (Describe) Nuvola® aligner is intended for the orthodontic treatment of malocclusion

Type of Use (Select one or both, as applicable)

> Prescription Use (Part 21 CFR 801 Subpart D)

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Image /page/3/Picture/0 description: The image shows a logo for "GEO GRUPPO EUROPEO DI ORTODONZIA". The logo features a blue globe with the letters "GEO" in large, bold, blue font across the center. The text "GRUPPO EUROPEO DI ORTODONZIA" is arranged in a circular fashion around the bottom half of the globe. The globe has visible lines of longitude and latitude.

K222418

# 510(k) SUMMARY

## Gruppo Europeo Ortodonzia srl (G.E.O. srl ) – Nuvola®

#### General Information

| 510(k) Sponsor | Gruppo Europeo Ortodonzia srl (GEO S.r.l.) |
|-------------------------|----------------------------------------------------|
| Address | via Cropani, 118 A/B<br>00173 - Rome, Italy |
| FDA Registration Number | --- |
| Contact Person | Massimiliano Bucceri<br>CEO and Founder |
| Contact Information | [e-mail]<br>[phone] |
| Date Prepared | 05 August 2022 |

#### Name of Device and Name/Address of Sponsor

| Name of Device | Nuvola |
|-------------------------|-------------------------------------------------------------------------------------------|
| Name/Address of Sponsor | Gruppo Europeo Ortodonzia srl (GEO S.r.l.)<br>via Cropani, 118 A/B<br>00173 - Rome, Italy |
| Trade/Proprietary Name | Nuvola® |
| Common Name | Aligner, Sequential |
| Classification Name | Orthodontic Plastic Bracket |

#### Predicate Device

| Name of Device | Invisalign System |
|-------------------------|-------------------------------------------------------------------|
| Name/Address of Sponsor | Align Technology, Inc. , 2820 Orchard Parkway, San Jose, CA 95134 |
| Trade/Proprietary Name | Invisalign System (K220287) |
| Common Name | Aligner, Sequential |
| Classification Name | Orthodontic Plastic Bracket |

Image /page/3/Picture/10 description: The image contains the logo for Nuvola. The logo consists of the word "nuvola" in lowercase letters, with a stylized "N" symbol above it. The "N" symbol is made up of four curved shapes that are arranged in a circular pattern. The word "nuvola" is in a dark gray color, and the "N" symbol is in a light teal color.

G.E.O. S.r.I. (Gruppo Europeo di Ortodonzia) Via Cropani, 118 A/B 00173 – Roma (Italia) [phone] [e-mail] www.nuvolaortodonzia.it

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Image /page/4/Picture/0 description: The image shows a logo for "GEO GRUPPO EUROPEO DI ORTODONZIA". The logo features a blue globe with visible continents and longitudinal lines. The text "GEO" is written in large, bold blue letters across the center of the globe. The full name of the organization, "GRUPPO EUROPEO DI ORTODONZIA", is written in a circular fashion around the bottom half of the globe.

#### Reference Device

| Name of Device | Ortho Aligner System |
|-------------------------|---------------------------------------------------------------|
| Name/Address of Sponsor | Ortho Lab Services LLC, 251 Little Falls Wilmington, DE 19808 |
| Trade/Proprietary Name | Ortho Aligner System (K212496) |
| Common Name | Aligner, Sequential |
| Classification Name | Orthodontic Plastic Bracket |

#### Intended Use

#### 1. Device description

The Nuvola® device is a doctor-prescribed series of removable plastic aligners intended as an alternative to conventional wire and bracket technology. The Nuvola® gently moves teeth in small increments from their original state to a final, treated state for improved dental alignment. The system is used in patients with primary, mixed, and permanent dentition. The system consists of a series of doctor prescribed and customized plastic aligners (thermoformed PET-G sheeting material) that gently move the patient's teeth in rements from their original state to a more optimal, treated state to address malocclusion. The first device of the treatment matches the patient's dentition in its current state and then each subsequent aligner stage of the dentition shifted gradually toward the final desired position.

The main phases of Nuvola® production are described in the following:

The manufacturing process start with obtaining the dimensions and details of the patient's baseline dentition from the prescribing clinician who takes scans of the patient's teeth and upload them into Nuvola®Web software. The scanned data (digital CAD/CAM model) are imported into specialized dental software for treatment planning (Nuvola®Web). Specialized orthodontic CAD/CAM software will be used to develop the treatment plans and to produce standard 3D printer files that will facilitate the manufacturing of each sequential aligner in the software application used for the manufacturing validation in this submission is the 3Shape Ortho System (K152086).

The Nuvola®Web software displays a series of 3-D dentition images with virtual tooth movements set up based on the doctor's prescription. The treating dental practitioner reviews these images and has the option to reject or request modifications to the set-up prior to approving it for aligner fabrication. Once the doctor approves the set-up, based on this set-up a custom-made series of thermoplastic polymer aligners are then manufactured at the aligner manufacturing facility. 3D printers are used to create the molds needed for each treatment step to provide the surface around which the aligner is thermoformed.

The final step is the thermoforming of a plastic sheet material treatment steps. This process is done using a standard thermoforming equipment and the appropriate material as outlined in this submission. The thermoformed aligners are sent back to the dentist for distribution to the patient in sequential stages and that the dentist checks the aligners for fit and function and monitors the first aligner until treatment is completed.

Image /page/4/Picture/10 description: The image shows the logo for Nuvola. The logo consists of a stylized teal-colored symbol resembling a stylized letter 'N' or a curved shape, positioned above the word "nuvola" in a dark gray, sans-serif font. The 'a' in "nuvola" has a registered trademark symbol next to it.

G.E.O. S.r.I. (Gruppo Europeo di Ortodonzia) Via Cropani, 118 A/B 00173 - Ron [e-mail] www.nuvolaortodonzia.it

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Image /page/5/Picture/0 description: The image shows a logo for GEO, which stands for Gruppo Europeo di Ortodonzia. The logo features a blue globe with white outlines of the continents. The letters "GEO" are written in blue across the globe. The full name of the organization, "GRUPPO EUROPEO DI ORTODONZIA", is written in a circular fashion around the bottom half of the globe.

#### 2. Indications for Use

Nuvola® aligner is intended for the orthodontic treatment of malocclusion.

#### 3. Non-clinical studies and tests performed

Non-clinical tests have been conducted to verify that the Nuvola® aligner meets all design specifications which supports the conclusion that it's Substantially Equivalent (SE) to the predicate and reference devices. The following Non-clinical studies and tests were conducted and are summarized in the table below:

| Manufacturing validation | Manufacturing validation was performed to verify that the<br>manufacturing process for Nuvola® Aligner complies with the pre-<br>established specifications and acceptance criteria. |
|----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Biocompatibility Testing | Biocompatibility was assessed in accordance with ISO 10993-1. The<br>tests on the material Erkodur have been performed by the supplier<br>of the material itself. |
| Shelf life | A 1-year shelf life was determined by real-time aging testing |
| Packaging | Package integrity, via simulated transport test per ISTA 2A, has been<br>performed |
| Treatment Planning software validation | Nuvola®Web (treatment plan platform) is validated by G.E.O in<br>accordance with IEC 62304:2006+AMD1:2015 and it turned out<br>compliance with 21 CFR part 11. |

#### 3.1 Manufacturing validation

Manufacturing accuracy validation was performed to demonstrate the manufacturing process for Nuvola® Aligner. Two critical aspects of the manufacturing process were assessed:

- digital dentition models from treatment planning and they 3D printed molds, and
- . the fitting of the first final thermoformed aligner

The test has been repeated for 5 times with 5 different patient 3rd party software was used to perform point-to-point and critical displacement. All measurements were within the predefined tolerance of the manufacturing process. There were no differences in the intended and measured in any cases used, meeting the pre-established specification. The suitability, function and form of the aligner were checked by the prescribing doctor make the patient worn the first aligner of the 5 treatment plans used for the validation, also in this case the results were comply with the pre-established specifications and acceptance criteria.

#### 3.1.1 Material used

The material used to produce Nuvola aligner is a Thermoforming Sheet Material indication of orthodontic and dental appliances (Erkodur, K200125). The material are pre-shaped flat plastic discs. The sheets are plasticized in appropriate thermoforming units and adapted onto patient's individual plaster models. After cooling the sheets are removed from the model and trimmed to fit. The use of thermoplastic materials for sequential aligners intended to treat malocclusions has been well documented in scientific literature regarding incremental tooth moving forces. All of the components found in Thermoforming Sheet Material have been used in legally marketed devices and/or were found safe for dental use.

Image /page/5/Picture/13 description: The image shows the logo for Nuvola. The logo consists of a stylized letter N in a teal color, positioned above the word "nuvola" in a dark gray sans-serif font. The letter N is designed with rounded edges and a curved shape, giving it a modern and abstract appearance.

Gruppo Europeo di Or Via Cropani. 118 A/B 00173 -

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Image /page/6/Picture/0 description: The image shows a logo for "GEO GRUPPO EUROPEO DI ORTODONZIA". The logo features a blue globe with white grid lines, suggesting a global or international focus. The text "GEO" is prominently displayed across the center of the globe, and the full name of the organization is written in a circular fashion around the bottom half of the globe.

#### 3.2 Biocompatibility Testing

The material that is in direct contact with the patient is a thermoforming sheet material already cleared by FDA (K200125) and it has been tested on its biocompatibility. The tests on the material Erkodur have been performed according to the standard EN ISO 10993-1 and FDA Guidance Document No. FDA-2013-D-0350. Biological effects to be considered for leachable are cytotoxicity, mucosa irritation, acute systemic and sub-chronic toxicity, genotoxicity. The results of the testing prove that the insolubility of the Thermoforming Sheet Material is in compliance with EN ISO 10993-1 and FDA Guidance Document No. FDA-2013-D-0350 for the intended dental use.

#### 3.3 Shelf life

A 1-year shelf life was determined by real-time aging testing were conducted after 24 months realtime aging under standard storage condition. The test results showed conformity with the precifications and acceptance criteria. For a conservative choice, it was decided to fix as shelf life to 12 months (1 year)

#### 3.4 Packaging

Package integrity, via simulated transport test per ISTA 2A, has been performed. The Nuvola® packaging is suitable for transportation and storage.

#### 3.5 Treatment Planning software validation

In order to support Nuvola® business, GEO has been developing a web-based platform called Nuvola®Web. This software is a Treatment Planning platform that allows users to manage in digital way the aligner treatment plan. Nuvola®Web is a classic web-based collaborative application dedicated to dentists who wish to request, manage the design and repair Nuvola® device which is a custom-made invisible aligner, upon presentation of a medical prescription.

Nuvola® Web is able to store all information in order to provide the user (doctor/dentist), with access to the application platform, a customized experience according to their preferences. Contact details, telephone and e-mail addresses, shipping and billing addresses. Once registered, the user is able to independently register the references of their patients, upload photographs, digitized dental impressions and diagnostic elements in electronic format (the main graphic standards are supported). Once the necessary information and medical prescription have been completed, it is possible to request and develop a treatment project designed to illustrate, through a three-dimensional (3D) graphic support, the evolution of dental movements, from the initial patient situation to the treatment. The platform includes a sophisticated 3D graphics feature, with the ability to show and store orthodontic information such as attachment points, inter-proximal reduction, etc. Nuvola®Web is able to simultaneously but separately manage the two arches (lower and upper), managing and accounting for the number of aligners necessary to carry out the clinical project goals, in order to meet all the needs of the associated prescription and consequently of the patient treatment. Doctor is able to interact with the laboratory through multi-channel communication techniques (chat, web request, email, etc.) in order to refine and agree on the details of the treatment proposal. Once all the clinical aspects have been determined, the application platform is able to manage doctor's acceptance plan, to be followed up for the production phase. Once the treatment plan is approved by the doctor, the platform sends in digital format the images of the models agreed with the doctor to the 3D printers which will produce the necessary models according to the quantities and methods previously defined. Finally, the application tracks the production activities thus ensuring the correct shipping and billing of the product requested by the doctor.

Nuvola®Web is validated by G.E.O in accordance with IEC 62304:2006+AMD1:2015 and it turned out compliance with 21 CFR part 11.

Image /page/6/Picture/11 description: The image shows the logo for Nuvola. The logo consists of a stylized letter "N" in a teal color, positioned above the word "nuvola" in a gray sans-serif font. The "a" in "nuvola" has a registered trademark symbol next to it.

Via Cropani. 118 A/B 00173

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Image /page/7/Picture/0 description: The image shows a logo for "GEO GRUPPO EUROPEO DI ORTODONZIA". The logo features a blue globe with white lines representing continents and oceans. The acronym "GEO" is written in large, bold, light blue letters across the center of the globe. The full name of the organization, "GRUPPO EUROPEO DI ORTODONZIA", is written in a semi-circle around the bottom of the globe in black letters.

#### 4. Clinical Studies

Clinical Studies was not conducted for this 510(k) Notification. Clinical Performance testing was not needed to establish substantial equivalence to the predicate and reference devices. The above-mentioned non-clinical test data characterizes all performance aspects of the device based on well-established scientific and engineering principles.

#### 5. Comparison with Predicate Device

Proposed device and predicate device have indications for use, intended use, technological characteristics, and principle of operation.

In accordance with 21 CFR 807.92(a)(6) a summary of the technological characteristic's comparison of the proposed modified device to the predicate Device is provided below.

#### 6. Technological Characteristics comparison with the Predicate and Reference Devices

| | Subject Device | Predicate Device<br>K220287 | Reference Device<br>K212496 | Comparison |
|--------------------------------|-----------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|
| Device Name | Nuvola® aligner | Invisalign® System | Ortho Aligner System | |
| Manufacturer | Gruppo Europeo di<br>Ortodonzia S.r.l.<br>(G.E.O srl) | Align Technology, Inc. | Ortho Lab Services, LLC | |
| Classification<br>Regulation # | 21 CFR 872.5470 | 21 CFR 872.5470 | 21 CFR 872.5470 | Same |
| Name Product | Orthodontic Plastic Bracket | Orthodontic Plastic Bracket | Orthodontic Plastic Bracket | Same |
| Code | NXC | NXC | NXC | Same |
| Class | II | II | II | Same |
| Indications for<br>Use | Nuvola® aligner is intended<br>for the orthodontic<br>treatment of malocclusion. | The Invisalign System is<br>intended for the orthodontic<br>treatment of malocclusion. | The Ortho Aligner System is<br>indicated for the treatment of<br>tooth malocclusion in patients<br>with permanent dentition<br>(i.e. all second molars). | Same as predicate<br>device |
| Mode of Action | Sequential aligners apply<br>continuous gentle force to<br>the teeth and/or position<br>mandible forward. | Sequential aligners apply<br>continuous gentle force to the<br>teeth and/or position mandible<br>forward. | The appliance applies gentle<br>forces on teeth according to the<br>plan prescribed by the doctor. | Same |

Image /page/7/Picture/8 description: The image features the logo for Nuvola. The logo consists of a stylized letter 'N' formed by two curved shapes in a light teal color, positioned above the word 'nuvola' in a lowercase, sans-serif font. The word 'nuvola' is in a dark gray color, and a small registration mark is placed to the right of the 'a'.

G.E.O. S.r.l. (Gruppo Europeo di Or Via Cropani, 118 A/B 00173 [e-mail] www.nuvolaortodonzia.it

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Image /page/8/Picture/0 description: The image shows a logo for "GEO GRUPPO EUROPEO DI ORTODONZIA". The logo features a blue globe with visible continents and grid lines. The acronym "GEO" is prominently displayed in blue, block letters across the center of the globe. The full name of the organization, "GRUPPO EUROPEO DI ORTODONZIA", is written in a curved, sans-serif font around the lower portion of the globe.

| | Subject Device | Predicate Device<br>K220287 | Reference Device<br>K212496 | Comparison |
|-------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------|
| Device Description | Sequential thermoformed<br>plastic aligners | Sequential thermoformed<br>plastic aligners | Sequential thermoformed<br>plastic aligners | Same |
| Description of<br>Use | Aligners are worn for<br>approximately 1-2 weeks of<br>20- 22 hours of wear per day,<br>after which it is replaced by<br>the next stage aligners. This is<br>repeated for duration as<br>prescribed by the Dental<br>Practitioner. | Aligners are worn for<br>approximately 1-2 weeks of 20-<br>22 hours of wear per day, after<br>which it is replaced by the next<br>stage aligners. This is repeated<br>for duration as prescribed by<br>the Dental Practitioner. | Each removable preformed<br>plastic tray is worn by the<br>patient as prescribed by the<br>doctor, usually a few weeks<br>prior to using the next<br>sequential aligner tray. | Same |
| Patient<br>Population | Children, Adolescents and<br>Adults | Children, Adolescents and<br>Adults | Patients with permanent<br>dentition (i.e. all second molars) | Same |
| Material | Thermoplastic polymer PET-G | Thermoplastic polymer | Thermoplastic PET-G | Same material as<br>reference<br>device |
| Material<br>Properties | Acceptable materials<br>properties established for use<br>as aligner (polyethylene<br>terephthalate glycol PET-G)<br>Erkodur (K200125) | SmartTrack™ is material<br>engineered for use with<br>Invisalign orthodontic treatment<br>(Polyurethane) | Polyethylene terephthalate<br>glycol, PET-G) | Similar material to<br>predicate device.<br>Same as reference<br>device |
| Manufacturing<br>Process | Thermoforming on models | Thermoforming on models | Thermoforming on models | Same |
| Manufacturing<br>Process Validation | An internal manufacturing<br>Process Validation was<br>performed | An internal manufacturing<br>Process Validation was<br>performed | Testing to validate the<br>manufacturing process was<br>performed. | Same |
| Treatment<br>Planning software | Nuvola® Web software is a<br>web-based collaborative<br>application that allows the<br>user to manage in digital way<br>the aligner treatment plan | ClinChek® software Cloud-based<br>technology that allows you to<br>manage in digital way the<br>aligner treatment plan | Ortho Lab Services uses their<br>OrthoWare software to design<br>the treatment plans for tooth<br>movement | Similar to predicate<br>device: same<br>purpose but<br>different<br>technologies |

Image /page/8/Picture/2 description: The image shows the logo for Nuvolo. The logo consists of a stylized letter "N" in a light blue color, positioned above the word "nuvolo" in lowercase letters. To the right of the word "nuvolo" is the registered trademark symbol. There are also the letters "DLC" in the image.

G.E.O. S.r.I. (Gruppo Europeo di Ortodonzia) Via Cropani, 118 A/B 00173 – Roma (Italia) [phone] [e-mail] www.nuvolaortodonzia.it

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Image /page/9/Picture/0 description: The image shows a logo for GEO, which stands for Gruppo Europeo di Ortodonzia. The logo features a blue globe with continents outlined in white. The letters "GEO" are superimposed on the globe in a stylized, blue font. The full name of the organization, "GRUPPO EUROPEO DI ORTODONZIA," is written in a circular fashion around the globe.

| | Subject Device | Predicate Device<br>K220287 | Reference Device<br>K212496 | Comparison |
|-----------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------|
| Software<br>Description for<br>tooth movement | 3Shape Ortho System<br>(K152086) dental software<br>for tooth alignment uses<br>digital scan (untreated state)<br>to generate the image of a<br>final, provisional treated<br>state and then interprets a<br>series of images that<br>represent intermediate teeth<br>states. The dental<br>practitioner then reviews<br>these images and has the<br>option to reject or request<br>modifications to the set-up<br>prior to approving it for<br>aligner fabrication. Once the<br>dental practitioner approves<br>the treatment plan, the<br>sottware converts the files to<br>produce the series of 3D<br>models used to produce<br>thermoformed aligners | Invisalign System 3-D Software<br>(K081960) Produces 3Dmodel<br>file of the PVS impression or the<br>digital scan. Identifies the<br>individual teeth that require<br>treatment (i.e., repositioning).<br>Creates a treatment plan (i.e., 3-<br>D models that represent the<br>treatment plan) which is<br>reviewed by the treating dental<br>practitioner using function to<br>reject or request modifications<br>to the set-up prior to approval. | OrthoWare software uses digital<br>scans to generate images of the<br>final treated states, and<br>intermediate steps to achieve<br>the final state, and convert<br>those files to produce the series<br>of customized aligners | Same purpose of<br>the predicate<br>device |
| Prescription<br>Use | Rx only | Rx only | Rx only | Same |
| Single Patient | Yes | Yes | Yes | Same |
| Biocompatibility | Meets ISO 10993-1, -5, -10<br>requirements: Cytotoxicity<br>and<br>Sensitization/Irritation | Biocompatible in according<br>to ISO 10993-1 | Meets ISO 10993-1, -5, -10<br>requirements: Cytotoxicity<br>and Sensitization/Irritation | Same |
| Process Flow<br>Validation Testing | Performed testing to<br>validate the finished<br>device matches the<br>software output design. | Performed testing to<br>validate the finished device<br>matches the software<br>output design. | Performed testing to<br>validate the finished device<br>matches the software<br>output design. | Same |

Image /page/9/Picture/2 description: The image contains the logo for Nuvolo. The logo consists of a stylized teal-colored symbol above the word "nuvolo" in a sans-serif font. There is a registered trademark symbol to the right of the word "nuvolo". The letters "DLC" are present below the word "nuvolo".

G.E.O. S.r.I. (Gruppo Europeo di Ortodonzia) Via Cropani, 118 A/B 00173 – Roma (Italia) [phone] [e-mail] www.nuvolaortodonzia.it

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Image /page/10/Picture/0 description: The image shows a logo for GEO, which stands for Gruppo Europeo di Ortodonzia. The logo features a blue globe with the letters "GEO" in a stylized font across the center. The text "GRUPPO EUROPEO DI ORTODONZIA" is written around the bottom half of the globe in a semi-circular fashion. The globe has visible lines of longitude and latitude.

#### 7. Differences

| | Subject Device | Predicate Device<br>K220287 | Reference Device<br>K212496 | Comparison |
|------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------|
| Treatment<br>Planning software | Nuvola® Web software is a<br>web-based collaborative<br>application that allows the<br>user to manage in digital<br>way the aligner treatment<br>plan | ClinChek® software<br>Cloud-based technology that<br>allows you to manage in digital<br>way the aligner treatment plan | Information not available | Similar to predicate<br>device: same<br>purpose but<br>different<br>technologies |
| 3D software for<br>tooth alignment | 3Shape Ortho System<br>(K152086) | Invisalign System 3-D Software<br>(K081960) | Information not available | Similar to predicate<br>device. |
| Material<br>Properties | Acceptable materials<br>properties established for<br>use as aligner (PET-G).<br>Erkodur (K200125) | SmartTrack™ is material<br>engineered for use with<br>Invisalign orthodontic treatment<br>(Polyurethane) | Acceptable materials properties<br>established for use as aligner<br>(PET-G) | Same as the<br>Reference device.<br>Similar material<br>type to the<br>predicate device |

The subject and predicate device use similar material type, both PET-G and Polyurethane for dental application have similar characteristics. The thermoplastic polymer used by Nuvola® is PET-G, already FDA cleared Erkodur (K200125), that is one of most used the plastic materials to produce dental aligner, and it is the same used by the Reference Device. The software used for the management of the treatment plan between Subject and Predicate device are different: the Nuvola® Web is a web-based software whereas ClinChek® is a Cloud-based technology software; but they have the same purpose and are used in a similar way. Therefore, the using of different Treatment Planning software does not raise any questions regarding safety and effectiveness.

Regarding the dental software for tooth alignment G.E.O uses the already FDA cleared software 3Shape Ortho System (K152086) while Align Inc. uses a proprietary software: Invisalign System 3-D Software (K081960). They both use digital scans to generate images of the final treated states, and intermediate steps to achieve the final state, and convert those files to produce the series of customized aligners.

#### 8. Substantial Equivalence

The Nuvola® (Subject Device) and the previously cleared predicate device Invisalign System are similar in that they have:

- same indications for use,
- . same principles of operation
- same technological characteristics, and
- same manufacturing process

#### 9. Conclusion

The Nuvola® device has the same intended use and indications for use as the previously cleared Invisalign System (K220287). In addition, the Nuvola® system has the same technological characteristics, and principles of operation as its predicate and reference device.

The software and materials differences between the Nuvola® system and its predicate device do not raise new questions of safety or efficacy.

Thus, the Nuvola® device is substantially equivalent previously cleared similar devices.

Image /page/10/Picture/15 description: The image shows the logo for Nuvola. The logo features a stylized letter "N" above the word "nuvola". The "N" is formed by two curved shapes that resemble wings or clouds, and it is colored in a light teal. The word "nuvola" is written in a lowercase, sans-serif font and is colored in gray.

G.E.O. S.r.l. (Gruppo Europeo di Or Via Cropani. 118 A/B 00173