(245 days)
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.
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.
The provided document does not contain information regarding the acceptance criteria of a device based on a study, nor does it detail a study that proves the device meets specific acceptance criteria related to its performance in terms of diagnostic accuracy or similar metrics.
The document is a 510(k) Premarket Notification from the FDA, and it primarily focuses on establishing "substantial equivalence" of the Blue Sky Bio Aligner G & Blue Sky Plan Software for Blue Sky Bio Aligner G to legally marketed predicate devices. This process relies on demonstrating that the new device has the same intended use and similar technological characteristics to a predicate device, and that any differences do not raise new questions of safety or effectiveness.
Here's what can be extracted from the document concerning performance and testing, and why it doesn't fit the requested format for acceptance criteria and a study proving performance:
1. A table of acceptance criteria and the reported device performance:
This information is not present in the document. The document discusses non-clinical performance testing for the physical aligner G product (Blue Sky Bio Aligner G) for material properties, but it does not specify performance acceptance criteria for the software component (Blue Sky Plan Software) or the combined system related to its orthodontic function (e.g., accuracy of tooth movement prediction, clinical outcome metrics).
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
No such test set data, sample size, or provenance is described for either the aligner or the software's clinical performance. The document explicitly states: "No human clinical testing was performed to support the substantial equivalence of Blue Sky Bio Aligner G."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
This information is not applicable as no clinical performance study involving a test set with expert-established ground truth was conducted or described for regulatory submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable as no clinical performance study involving a test set was conducted or described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
This information is not applicable. The software, "Blue Sky Plan Software for Blue Sky Bio Aligner G," is described as a "medical front-end device providing tools for management of orthodontic models, systematic inspection, detailed analysis, treatment simulation and virtual design." It is a planning and design tool, not an AI assistance tool for human readers in a diagnostic capacity that would typically require MRMC studies. The document does not suggest AI assistance for "human readers," but rather a tool for clinicians to design treatments.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
While the software performs functions, the document does not describe a standalone performance study in a manner that would typically be associated with AI algorithms (e.g., a specific diagnostic accuracy metric without human intervention). Its use is explicitly described as requiring "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," indicating a human-in-the-loop workflow.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable as no clinical performance study requiring ground truth was described. The "ground truth" for the device's function is the clinical outcome achieved by the orthodontist using the tool and aligners, but this is not assessed in a study for this 510(k) submission.
8. The sample size for the training set:
This information is not present. The document does not describe the development or training of an AI algorithm that would typically involve a training set. The software is described as a "medical front-end device providing tools," implying a software tool for design and management rather than a machine learning model that requires training data in the context of typical AI device submissions.
9. How the ground truth for the training set was established:
This information is not present as no training set or AI algorithm training is described.
Summary of Device Performance and Acceptance Criteria from the Document:
The document focuses on substantiating equivalence primarily through:
- Material Composition: "Blue Sky Bio Aligner G is composed of a methacrylate-based resin." This is compared to predicate devices.
- 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." And "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; ISO 7405:2018." "Biocompatibility testing has shown that Blue Sky Bio Aligner G is safe and biocompatible for the stated intended use."
- Technological Characteristics Comparison: A detailed table (pages 8-9) compares the new device's indications, FDA product code, physical/clinical properties, technical attributes, and software attributes to predicate and reference devices.
Conclusion based on the provided text:
The provided FDA 510(k) document does not contain the type of acceptance criteria and detailed study data (e.g., sample sizes, ground truth establishment, expert qualifications, MRMC studies) typically associated with the performance evaluation of a device, especially an AI/ML diagnostic or prognostic tool, as requested in your prompt. This document is instead a demonstration of "substantial equivalence" based on similar intended use and technological characteristics, supported by bench testing of material properties and biocompatibility. The regulatory submission path for this device did not require human clinical trials to demonstrate specific performance metrics like those for diagnostic accuracy.
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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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FORM FDA 3881 (6/20)
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510(k) Summary - K221845
| Submitter | Blue Sky Bio, LLC800 Liberty DriveLibertyville, IL 60048Establishment Reg. No. 3003402534 |
|---|---|
| Contact | Dr. Albert ZickmannVP, Product DevelopmentPhone 718 376-0422E-Mail azickman@blueskybio.com |
| Official Correspondent | Nevine Erian |
|---|---|
| Regulatory Consultant | |
| BQC Consulting, LLC | |
| 24341 Barbados Dr. | |
| Dana Point, CA 92629 | |
| Phone (949) 370-7155 | |
| E-mail nevine@bqcconsulting.com |
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 872.5470Orthodontic 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 AlignerG & Blue Sky PlanS/W for Blue Sky BioAligner G | Arcad AlignerSystem & ArcadSmileStudio(Primary Predicate) | Blue Sky Bio Aligner(Reference Device) | Tera Harz Clear(Reference Device) |
|---|---|---|---|---|
| Indications | ||||
| Software is intended for use as a medical front-end device providing tools for management oforthodontic models, systematic inspection,detailed analysis, treatment simulation andvirtual design of a series of dental casts, whichmay be used for sequential aligner trays orretainers, based on 3D models of the patient'sdentition before the start of an orthodontictreatment. It can also be applied during thetreatment to inspect and analyze the progress ofthe treatment. It can be used at the end of thetreatment to evaluate if the outcome isconsistent with the planned/desired treatmentobjectives. | Yes | Yes | Yes | No - Does notinclude software |
| Device is a series of clear, lightweight, plasticappliances indicated for the treatment of toothmalocclusions in patients with permanentdentition (i.e. all second molars). | Yes | Yes | Yes | Yes |
| Utilizing a series of incremental toothmovements, device sequentially positions teethby way of continuous gentle force. | Yes | Yes | Yes | Yes |
| FDA Product Code | NXC & PNN | NXC & PNN | NXC | NXC |
| Attribute | Blue Sky Bio AlignerG & Blue Sky PlanS/W for Blue Sky BioAligner G | Arcad AlignerSystem & ArcadSmileStudio(Primary Predicate) | Blue Sky Bio Aligner(Reference Device) | Tera Harz Clear(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 toothmovement throughforces applied by theappliance to thedentition as eachtooth follows theprogrammeddisplacement basedon a doctor'sprescription. | Orthodontic toothmovement throughforces applied by theappliance to thedentition as eachtooth follows theprogrammeddisplacement basedon a doctor'sprescription. | Orthodontic toothmovement throughforces applied by theappliance to thedentition as eachtooth follows theprogrammeddisplacement basedon a doctor'sprescription. | Orthodontic toothmovement throughforces applied bythe appliance to thedentition as eachtooth follows theprogrammeddisplacement basedon a doctor'sprescription. |
| In Use Duration | Each aligner is wornfor 2 weeks for 20-22hours of wear perday | Each aligner is wornfor 2 weeks for 20-22hours of wear perday | Each aligner is wornfor 2 weeks for 20-22hours of wear perday | Each aligner is wornfor 2 weeks for 20-22 hours of wearper day |
| Sterile | No | No | No | No |
| Single Use | No | No | No | No |
| Rx or OTC | Rx | Rx | Rx | Rx |
| Attribute | Blue Sky Bio AlignerG & Blue Sky PlanS/W for Blue Sky BioAligner G | Arcad AlignerSystem & ArcadSmileStudio(Primary Predicate) | Blue Sky Bio Aligner(Reference Device) | Tera Harz Clear(Reference Device) |
| Technical Attributes | ||||
| Chemical Characterization | Methacrylate-basedresins with photoinitiators | Polyurethane resins | Polypropylene/ethylene copolymer | Methacrylate-basedresins with photoinitiators |
| Fabrication Method | 3D printed & cured | VacuumThermoformed | VacuumThermoformed | 3D printed & cured |
| 3 D Printer | SprinRay Pro 95 | n/a | n/a | SprinRay Pro 95 &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 BlueSky Bio Aligner G | Arcad SmileStudio | Blue Sky Plan for BlueSky Bio Aligner | 3Shape OrthoSystem™ |
| Software Attributes | ||||
| Import of Digital Orthodontic Models | Import andmanagement ofdigitalorthodontic modelsfrom patient scans | Import andmanagement ofdigitalorthodontic modelsfrom patient scans | Import andmanagement ofdigitalorthodontic modelsfrom patient scans | No S/W included |
| Attribute | Blue Sky Bio AlignerG & Blue Sky PlanS/W for Blue Sky BioAligner G | Arcad AlignerSystem & ArcadSmileStudio(Primary Predicate) | Blue Sky Bio Aligner(Reference Device) | Tera Harz Clear(Reference Device) |
| Sequential Aligners Design | Uses a scan of toothimpression or adigital scan togenerate the imageof a final treatedstate and theninterprets a series ofimages thatrepresentintermediate teethstates. The softwareconverts the files toproduce a series ofpatient specificmolds and convertsthe mold files intoSTL files for 3Dprinted aligners. | Uses a scan of toothimpression or adigital scan togenerate the imageof a final treatedstate and theninterprets a series ofimages thatrepresentintermediate teethstates. The S/Wconverts the files toproduce the series ofpatient specificmolds which are 3Dprinted, so alignersare vacuumthermoformed overthe molds. | Uses a scan of toothimpression or adigital scan togenerate the imageof a final treatedstate and theninterprets a series ofimages thatrepresentintermediate teethstates. The S/Wconverts the files toproduce the series ofpatient specificmolds which are 3Dprinted, so alignersare vacuumthermoformed overthe molds. | No S/W included |
| Digital Imaging Tools | Software is used asan aid to diagnosisand for treatmentplanning by theclinician | Software is used asan aid to diagnosisand for treatmentplanning by theclinician | Software is used asan aid to diagnosisand for treatmentplanning by theclinician | No S/W included |
| Attribute | Blue Sky Bio AlignerG & Blue Sky PlanS/W for Blue Sky BioAligner G | Arcad AlignerSystem & ArcadSmileStudio(Primary Predicate) | Blue Sky Bio Aligner(Reference Device) | Tera Harz Clear(Reference Device) |
| Teeth Segmentation | Segment individualteeth within themodel to allowindependent digitalmovement of theteeth | Segment individualteeth within themodel to allowindependent digitalmovement of theteeth | Segment individualteeth within themodel to allowindependent digitalmovement of theteeth | No S/W included |
| Planning of Orthodontic Treatments | Virtual planning oforthodontictreatmentssimulating toothmovements | Virtual planning oforthodontictreatmentssimulating toothmovements | Virtual planning oforthodontictreatmentssimulating toothmovements | No S/W included |
| Export of Data Format | Export data asStereolithography(STL file format) | Export data asStereolithography(STL file format) | Export data asStereolithography(STL file format) | No S/W included |
| STL File Type | Export STL files of alayer of a definedthicknesscorresponding to thenegative of a seriesof models. The STLfiles are intended tomanufacture directlyprinted aligners | Export STL files forprinting a series ofmodels. The modelsare to be used as abasis forthermoformedaligners | Export STL files forprinting of a series ofmodels. The modelsare to be used as abasis forthermoformedaligners | No S/W included |
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The physical, chemical and technological differences between Blue Sky Bio Aligner G & Blue Sky Plan Software for Blue Sky Bio Aligner G and the predicate devices do not impact safety and effectiveness, as the finished clinical product is a biocompatible aligner regardless of the difference in material and manufacturing method.
Conclusion
Information provided in this application demonstrates that Blue Sky Bio Aligner G & Blue Sky Plan Software for Blue Sky Bio Aligner G & Blue Sky Plan Software for Blue Sky Bio Aligner G are substantially equivalent to the predicate devices. Blue Sky Bio Aligner G & Blue Sky Plan Software for Blue Sky Bio Aligner G share the same indications for use, similar material composition, similar physical properties and technological characteristics as the predicate devices.
§ 872.5470 Orthodontic plastic bracket.
(a)
Identification. An orthodontic plastic bracket is a plastic device intended to be bonded to a tooth to apply pressure to a tooth from a flexible orthodontic wire to alter its position.(b)
Classification. Class II.