Blue Sky Bio Aligner G & Blue Sky Plan S/W for Blue Sky Bio Aligner G

K221845 · Blue Sky Bio, LLC · NXC · Feb 24, 2023 · Dental

Device Facts

• Record ID: K221845
• Device Name: Blue Sky Bio Aligner G & Blue Sky Plan S/W for Blue Sky Bio Aligner G
• Applicant: Blue Sky Bio, LLC
• Product Code: NXC · Dental
• Decision Date: Feb 24, 2023
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 872.5470
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Blue Sky Plan software module for Blue Sky Bio Aligner G is intended for use as a medical frontend device providing tools for management of orthodontic models, systematic inspection, detailed analysis, treatment simulation and virtual design of a series of dental casts, which may be used for sequential aligner trays or retainers, based on 3D models of the patient's dentition before the start of an orthodontic treatment. It can also be applied during the treatment to inspect and analyze the progress of the treatment. It can be used at the end of the treatment to evaluate if the outcome is consistent with the planned/desired treatment objectives. Blue Sky Bio Aligner G is a series of clear, lightweight, plastic appliances indicated for the treatment of tooth malocclusions in patients with permanent dentition (i.e. all second molars). Utilizing a series of incremental tooth movements, it sequentially positions teeth by way of continuous gentle force. The use of the Blue Sky Bio Plan software module for Blue Sky Bio Aligner G 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

System comprises Blue Sky Plan software and Blue Sky Bio Aligner G clear plastic appliances. Clinician inputs patient dental impressions or intraoral scans (STL files) into software. Software enables management of orthodontic models, inspection, analysis, treatment simulation, and virtual design of dental casts. Clinician designs incremental tooth movements; reviews and approves digital model scheme. Dental lab 3D prints aligners using biocompatible methacrylate-based resin. Clinician provides sequential aligners to patient for wear (20-22 hours/day, 2-week intervals). Continuous gentle force moves teeth to target positions. Used in dental clinics by orthodontists/dentists to correct malocclusions and monitor treatment progress. Benefits include aesthetic, removable orthodontic correction.

Clinical Evidence

Bench testing only. No human clinical testing performed. Device met ISO 20795-2:2013 requirements for orthodontic base polymers and ISO 10993-1:2018/ISO 7405:2018 biocompatibility standards.

Technological Characteristics

3D printed clear aligners made of photo-curable methacrylate-based resin. Curing wavelength 405 nm; layer thickness 100 μm. Software-based design and planning. Non-sterile, multi-use, prescription-only. Complies with ISO 20795-2 and ISO 10993-1.

Indications for Use

Indicated for treatment of tooth malocclusions 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

• Arcad SmileStudio and Arcad Aligner System (K192244)

Reference Devices

• Blue Sky Bio Aligner (K180107)
• Tera Harz Clear (K223355)

Submission Summary (Full Text)

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February 24, 2023

Blue Sky Bio, LLC % Nevine Erian Regulatory Consultant BQC Consulting, LLC 24341 Barbados Dr. Dana Point, California 92629

Re: K221845

Trade/Device Name: Blue Sky Bio Aligner G & Blue Sky Plan S/W for Blue Sky Bio Aligner G Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: Class II Product Code: NXC, PNN Dated: January 24, 2023 Received: January 25, 2023

Dear Nevine Erian:

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. Adodha -S

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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## Indications for Use

510(k) Number (if known)

#### K221845

Device Name

#### Blue Sky Plan Software for Blue Sky Bio Aligner G and Blue Sky Bio Aligner G

Indications for Use (Describe)

Blue Sky Plan software module for Blue Sky Bio Aligner G is intended for use as a medical frontend device providing tools for management of orthodontic models, systematic inspection, detailed analysis, treatment simulation and virtual design of a series of dental casts, which may be used for sequential aligner trays or retainers, based on 3D models of the patient's dentition before the start of an orthodontic treatment. It can also be applied during the treatment to inspect and analyze the progress of the treatment. It can be used at the end of the treatment to evaluate if the outcome is consistent with the planned/desired treatment objectives.

Blue Sky Bio Aligner G is a series of clear, lightweight, plastic appliances indicated for the treatment of tooth malocclusions in patients with permanent dentition (i.e. all second molars). Utilizing a series of incremental tooth movements, it sequentially positions teeth by way of continuous gentle force.

The use of the Blue Sky Bio Plan software module for Blue Sky Bio Aligner G 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)

× Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)

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# 510(k) Summary - K221845

| Submitter | Blue Sky Bio, LLC<br>800 Liberty Drive<br>Libertyville, IL 60048<br>Establishment Reg. No. 3003402534 |
|-----------|--------------------------------------------------------------------------------------------------------|
| Contact | Dr. Albert Zickmann<br>VP, Product Development<br>Phone [phone]<br>E-Mail [e-mail] |

| Official Correspondent | Nevine Erian |
|------------------------|----------------------------------------|
| | Regulatory Consultant |
| | BQC Consulting, LLC |
| | 24341 Barbados Dr. |
| | Dana Point, CA 92629 |
| | <b>Phone</b> [phone] |
| | <b>E-mail</b> [e-mail] |

Date Prepared February 23, 2023

| Trade/Device Name | Blue Sky Bio Aligner G & Blue Sky Plan Software for Blue Sky Bio Aligner G |
|-------------------------------------------|---------------------------------------------------------------------------------|
| Common Name | Sequential Aligner |
| Classification Names & Regulation Numbers | Aligner, Sequential – 21 CFR 872.5470<br>Orthodontic Software – 21 CFR 872.5470 |
| Product Codes | NXC & PNN |

#### Predicate Devices

Arcad SmileStudio and Arcad Aligner System (ArcadLab, LLC) – K192244 – Primary Predicate

Blue Sky Bio Aligner (Blue Sky Bio, LLC) – K180107 – Reference Device I

Tera Harz Clear (Graphy, Inc.) – K223355 – Reference Device II

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# Device Description

The Blue Sky Bio Aligner G consists of a series of clear plastic aligner trays that offer a solution for aesthetic orthodontic treatment by utilizing a set of removable aligners to correct tooth malocclusions.

Blue Sky Bio Aligner G starts with the dental clinician prescribing aligners to treat a patient's malocclusion, and the decision to use a methacrylate-based resin for sequential aligners.

A dental clinician (e.g. orthodontist or dentist), using a standard personal computer prescribes the Blue Sky Bio Aligner G based on an assessment of the patient's teeth and determines the course of treatment, using Blue Sky Bio's Blue Sky Plan software (K180107). The clinician takes molds of the patient's teeth and completes a prescription form and sends the molds to the dental lab, which in turn scans the molds and uploads the .STL files of the molds in Blue Sky Plan software. This digital file is a series of CAD files (.STL) for building models that can be used to fabricate aligners. Alternatively, the dental clinician may generate the digital files by scanning the patient's mouth directly, using an intraoral scanner, and then sends the files to the dental lab.

The dental lab or the clinician designs a series of digital models and plastic trays intended to gradually realign the patient's teeth, using Blue Sky Plan software. The prescribing physician reviews and approves the model scheme before the aligners are produced. Once approved by the clinician, the dental lab produces the Blue Sky Bio Aligner G sequential aligners, which are 3D printed with a clear biocompatible resin.

The Blue Sky Bio Aligner G are sent to the dental clinician who then provides them to the patient, confirming fit and design. Over a period of time, additional trays are provided sequentially to the patient by the clinician to gradually move the target teeth to the designed position. The dental health professional monitors treatment from the moment the first aligner is delivered to when the final aligner is delivered. The trays are held in place by pressure and can be removed by the patient at any time.

# Indication for Use

Blue Sky Plan software module for Blue Sky Bio Aligner G is intended for use as a medical front-end device providing tools for management of orthodontic models, systematic inspection, detailed analysis, treatment simulation and virtual design of a series of dental casts, which may be used for sequential aligner trays or retainers, based on 3D models of the patient's dentition before the start of an orthodontic treatment. It can also be applied during the treatment to inspect and analyze the progress of the treatment. It can be used at the end of the treatment to evaluate if the outcome is consistent with the planned/desired treatment objectives.

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Blue Sky Bio Aligner G is a series of clear, lightweight, plastic appliances indicated for the treatment of tooth malocclusions in patients with permanent dentition (i.e. all second molars). Utilizing a series of incremental tooth movements, it sequentially positions teeth by way of continuous gentle force.

The use of the Blue Sky Bio Plan software module for Blue Sky Bio Aligner G requires the user to have the necessary training and domain knowledge in the practice orthodontics, as well as to have received a dedicated training in the use of the software.

## Material Composition

Blue Sky Bio Aligner G is composed of a methacrylate-based resin.

## Technological Characteristics

Blue Sky Bio Aligner G is 3D printed with a photo-curable resin.

## Non-Clinical Performance Testing

Blue Sky Bio Aligner G was tested and met the applicable requirements of ISO 20795-2:2013 – Dentistry – Base Polymers – Part 2: Orthodontic base polymers.

Bench test results allowed us to conclude that Blue Sky Bio Aligner G meets its intended use.

## Biocompatibility

Blue Sky Bio Aligner G meets the biocompatibility requirements of the following standards:

- . ISO 10993-1:2018 – Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process
- . ISO 7405:2018 Dentistry – Evaluation of Biocompatibility of Medical Devices Used in Dentistry

Biocompatibility testing has shown that Blue Sky Bio Aligner G is safe and biocompatible for the stated intended use.

## Clinical Performance Data

The performance of methacrylate-based resins in the clinical environment has been well established. No human clinical testing was performed to support the substantial equivalence of Blue Sky Bio Aligner G.

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# Substantial Equivalence

The technical characteristics of Blue Sky Bio Aligner G & Blue Sky Plan Software for Blue Sky Bio Aligner G are substantially equivalent to the predicate devices.

#### Material

Blue Sky Bio Aligner G is a resin-based material as the predicate devices.

#### Physical Properties

Blue Sky Bio Aligner G has similar physical properties as the primary predicate device.

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# Comparison to Predicate Devices

| Attribute | Blue Sky Bio Aligner<br>G & Blue Sky Plan<br>S/W for Blue Sky Bio<br>Aligner G | Arcad Aligner<br>System & Arcad<br>SmileStudio<br>(Primary Predicate) | Blue Sky Bio Aligner<br>(Reference Device) | Tera Harz Clear<br>(Reference Device) |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications | | | | |
| Software is intended for use as a medical front-<br>end device providing tools for management of<br>orthodontic models, systematic inspection,<br>detailed analysis, treatment simulation and<br>virtual design of a series of dental casts, which<br>may be used for sequential aligner trays or<br>retainers, based on 3D models of the patient's<br>dentition before the start of an orthodontic<br>treatment. It can also be applied during the<br>treatment to inspect and analyze the progress of<br>the treatment. It can be used at the end of the<br>treatment to evaluate if the outcome is<br>consistent with the planned/desired treatment<br>objectives. | Yes | Yes | Yes | No - Does not<br>include software |
| Device is a series of clear, lightweight, plastic<br>appliances indicated for the treatment of tooth<br>malocclusions in patients with permanent<br>dentition (i.e. all second molars). | Yes | Yes | Yes | Yes |
| Utilizing a series of incremental tooth<br>movements, device sequentially positions teeth<br>by way of continuous gentle force. | Yes | Yes | Yes | Yes |
| FDA Product Code | NXC & PNN | NXC & PNN | NXC | NXC |
| Attribute | Blue Sky Bio Aligner<br>G & Blue Sky Plan<br>S/W for Blue Sky Bio<br>Aligner G | Arcad Aligner<br>System & Arcad<br>SmileStudio<br>(Primary Predicate) | Blue Sky Bio Aligner<br>(Reference Device) | Tera Harz Clear<br>(Reference Device) |
| Physical & Clinical Properties | | | | |
| Material Initial State | Liquid | Solid | Solid | Liquid |
| Material Type | Photo-curable resin | Thermoplastic Resin | Thermoplastic Resin | Photo-curable Resin |
| Device Type | Clear Plastic Aligners | Clear Plastic Aligners | Clear Plastic Aligners | Clear Plastic Aligners |
| Mode of Action | Orthodontic tooth<br>movement through<br>forces applied by the<br>appliance to the<br>dentition as each<br>tooth follows the<br>programmed<br>displacement based<br>on a doctor's<br>prescription. | Orthodontic tooth<br>movement through<br>forces applied by the<br>appliance to the<br>dentition as each<br>tooth follows the<br>programmed<br>displacement based<br>on a doctor's<br>prescription. | Orthodontic tooth<br>movement through<br>forces applied by the<br>appliance to the<br>dentition as each<br>tooth follows the<br>programmed<br>displacement based<br>on a doctor's<br>prescription. | Orthodontic tooth<br>movement through<br>forces applied by<br>the appliance to the<br>dentition as each<br>tooth follows the<br>programmed<br>displacement based<br>on a doctor's<br>prescription. |
| In Use Duration | Each aligner is worn<br>for 2 weeks for 20-22<br>hours of wear per<br>day | Each aligner is worn<br>for 2 weeks for 20-22<br>hours of wear per<br>day | Each aligner is worn<br>for 2 weeks for 20-22<br>hours of wear per<br>day | Each aligner is worn<br>for 2 weeks for 20-<br>22 hours of wear<br>per day |
| Sterile | No | No | No | No |
| Single Use | No | No | No | No |
| Rx or OTC | Rx | Rx | Rx | Rx |
| Attribute | Blue Sky Bio Aligner<br>G & Blue Sky Plan<br>S/W for Blue Sky Bio<br>Aligner G | Arcad Aligner<br>System & Arcad<br>SmileStudio<br>(Primary Predicate) | Blue Sky Bio Aligner<br>(Reference Device) | Tera Harz Clear<br>(Reference Device) |
| Technical Attributes | | | | |
| Chemical Characterization | Methacrylate-based<br>resins with photo<br>initiators | Polyurethane resins | Polypropylene/ethylen<br>e copolymer | Methacrylate-based<br>resins with photo<br>initiators |
| Fabrication Method | 3D printed & cured | Vacuum<br>Thermoformed | Vacuum<br>Thermoformed | 3D printed & cured |
| 3 D Printer | SprinRay Pro 95 | n/a | n/a | SprinRay Pro 95 &<br>other printer |
| Curing Wavelength | 405 nm | n/a | Not applicable | 405 nm |
| Layer Thickness when Printing | 100 μm | n/a | Not applicable | 100 μm |
| Polymerization Method | Light Curing | n/a | Not applicable | Light Curing |
| Design Software Used | Blue Sky Plan for Blue<br>Sky Bio Aligner G | Arcad SmileStudio | Blue Sky Plan for Blue<br>Sky Bio Aligner | 3Shape Ortho<br>System™ |
| Software Attributes | | | | |
| Import of Digital Orthodontic Models | Import and<br>management of<br>digital<br>orthodontic models<br>from patient scans | Import and<br>management of<br>digital<br>orthodontic models<br>from patient scans | Import and<br>management of<br>digital<br>orthodontic models<br>from patient scans | No S/W included |
| Attribute | Blue Sky Bio Aligner<br>G & Blue Sky Plan<br>S/W for Blue Sky Bio<br>Aligner G | Arcad Aligner<br>System & Arcad<br>SmileStudio<br>(Primary Predicate) | Blue Sky Bio Aligner<br>(Reference Device) | Tera Harz Clear<br>(Reference Device) |
| Sequential Aligners Design | Uses a scan of tooth<br>impression or a<br>digital scan to<br>generate the image<br>of a final treated<br>state and then<br>interprets a series of<br>images that<br>represent<br>intermediate teeth<br>states. The software<br>converts the files to<br>produce a series of<br>patient specific<br>molds and converts<br>the mold files into<br>STL files for 3D<br>printed aligners. | Uses a scan of tooth<br>impression or a<br>digital scan to<br>generate the image<br>of a final treated<br>state and then<br>interprets a series of<br>images that<br>represent<br>intermediate teeth<br>states. The S/W<br>converts the files to<br>produce the series of<br>patient specific<br>molds which are 3D<br>printed, so aligners<br>are vacuum<br>thermoformed over<br>the molds. | Uses a scan of tooth<br>impression or a<br>digital scan to<br>generate the image<br>of a final treated<br>state and then<br>interprets a series of<br>images that<br>represent<br>intermediate teeth<br>states. The S/W<br>converts the files to<br>produce the series of<br>patient specific<br>molds which are 3D<br>printed, so aligners<br>are vacuum<br>thermoformed over<br>the molds. | No S/W included |
| Digital Imaging Tools | Software is used as<br>an aid to diagnosis<br>and for treatment<br>planning by the<br>clinician | Software is used as<br>an aid to diagnosis<br>and for treatment<br>planning by the<br>clinician | Software is used as<br>an aid to diagnosis<br>and for treatment<br>planning by the<br>clinician | No S/W included |
| Attribute | Blue Sky Bio Aligner<br>G & Blue Sky Plan<br>S/W for Blue Sky Bio<br>Aligner G | Arcad Aligner<br>System & Arcad<br>SmileStudio<br>(Primary Predicate) | Blue Sky Bio Aligner<br>(Reference Device) | Tera Harz Clear<br>(Reference Device) |
| Teeth Segmentation | Segment individual<br>teeth within the<br>model to allow<br>independent digital<br>movement of the<br>teeth | Segment individual<br>teeth within the<br>model to allow<br>independent digital<br>movement of the<br>teeth | Segment individual<br>teeth within the<br>model to allow<br>independent digital<br>movement…