(245 days)
No
The document describes software for treatment planning and design of aligners, but does not mention the use of AI or ML for any part of the process. The design is described as being performed by a dental lab or clinician using the software.
Yes
The device is a series of clear plastic aligner trays used to treat tooth malocclusions by sequentially positioning teeth through continuous gentle force, directly impacting the patient's physical condition.
No
The device, Blue Sky Plan software module for Blue Sky Bio Aligner G, is described as a "medical frontend device providing tools for management of orthodontic models, systematic inspection, detailed analysis, treatment simulation and virtual design." While it helps in analyzing and simulating treatment, its primary function is for planning and designing orthodontic aligners, not for diagnosing a medical condition. The diagnosis of malocclusion is performed by the dental clinician assessing the patient's teeth.
No
The device description clearly states that the Blue Sky Bio Aligner G consists of a series of clear plastic aligner trays, which are physical components. While the software is used for planning and design, the final medical device includes hardware (the aligners).
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device's Intended Use: The Blue Sky Plan software module and the Blue Sky Bio Aligner G are intended for the management of orthodontic models, treatment simulation, virtual design of dental casts, and the physical correction of tooth malocclusions.
- Nature of Input: The input is 3D models of the patient's dentition, derived from scans of impressions or intraoral scans. This is not a specimen taken from the human body for examination in the traditional IVD sense.
- Purpose: The purpose is to plan and execute orthodontic treatment, not to diagnose a disease or condition based on analysis of bodily fluids or tissues.
The device is clearly focused on the mechanical correction of a physical condition (malocclusion) using software for planning and physical aligners for treatment. This falls under the category of a medical device, specifically for orthodontics, but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
NXC, PNN
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Scans of tooth impression or digital scans from patient scans/intraoral scanner.
Anatomical Site
Dentition
Indicated Patient Age Range
Adults with permanent dentition (i.e. all second molars).
Intended User / Care Setting
Dental clinician (e.g. orthodontist or dentist) in a dental clinic/lab setting.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 and 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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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.
1
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
2
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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3
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FORM FDA 3881 (6/20)
Page 1 of 1
PSC Publishing Services (301) 443-6740 EF
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510(k) Summary - K221845
| Submitter | Blue Sky Bio, LLC
800 Liberty Drive
Libertyville, IL 60048
Establishment Reg. No. 3003402534 |
|-----------|--------------------------------------------------------------------------------------------------------|
| Contact | Dr. Albert Zickmann
VP, Product Development
Phone 718 376-0422
E-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 872.5470 |
| 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.
6
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
G & Blue Sky Plan
S/W for Blue Sky Bio
Aligner G | Arcad Aligner
System & Arcad
SmileStudio
(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 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. | Yes | Yes | Yes | No - Does not
include software |
| Device 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). | Yes | Yes | Yes | Yes |
| Utilizing a series of incremental tooth
movements, device sequentially positions teeth
by way of continuous gentle force. | Yes | Yes | Yes | Yes |
| FDA Product Code | NXC & PNN | NXC & PNN | NXC | NXC |
| Attribute | Blue Sky Bio Aligner
G & Blue Sky Plan
S/W for Blue Sky Bio
Aligner G | Arcad Aligner
System & Arcad
SmileStudio
(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 tooth
movement through
forces applied by the
appliance to the
dentition as each
tooth follows the
programmed
displacement based
on a doctor's
prescription. | Orthodontic tooth
movement through
forces applied by the
appliance to the
dentition as each
tooth follows the
programmed
displacement based
on a doctor's
prescription. | Orthodontic tooth
movement through
forces applied by the
appliance to the
dentition as each
tooth follows the
programmed
displacement based
on a doctor's
prescription. | Orthodontic tooth
movement through
forces applied by
the appliance to the
dentition as each
tooth follows the
programmed
displacement based
on a doctor's
prescription. |
| In Use Duration | Each aligner is worn
for 2 weeks for 20-22
hours of wear per
day | Each aligner is worn
for 2 weeks for 20-22
hours of wear per
day | Each aligner is worn
for 2 weeks for 20-22
hours of wear per
day | Each aligner is worn
for 2 weeks for 20-
22 hours of wear
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
G & Blue Sky Plan
S/W for Blue Sky Bio
Aligner G | Arcad Aligner
System & Arcad
SmileStudio
(Primary Predicate) | Blue Sky Bio Aligner
(Reference Device) | Tera Harz Clear
(Reference Device) |
| Technical Attributes | | | | |
| Chemical Characterization | Methacrylate-based
resins with photo
initiators | Polyurethane resins | Polypropylene/ethylen
e copolymer | Methacrylate-based
resins with photo
initiators |
| Fabrication Method | 3D printed & cured | Vacuum
Thermoformed | Vacuum
Thermoformed | 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 Blue
Sky Bio Aligner G | Arcad SmileStudio | Blue Sky Plan for Blue
Sky Bio Aligner | 3Shape Ortho
System™ |
| Software Attributes | | | | |
| Import of Digital Orthodontic Models | Import and
management of
digital
orthodontic models
from patient scans | Import and
management of
digital
orthodontic models
from patient scans | Import and
management of
digital
orthodontic models
from patient scans | No S/W included |
| Attribute | Blue Sky Bio Aligner
G & Blue Sky Plan
S/W for Blue Sky Bio
Aligner G | Arcad Aligner
System & Arcad
SmileStudio
(Primary Predicate) | Blue Sky Bio Aligner
(Reference Device) | Tera Harz Clear
(Reference Device) |
| Sequential Aligners Design | Uses a scan of tooth
impression or a
digital scan to
generate the image
of a final treated
state and then
interprets a series of
images that
represent
intermediate teeth
states. The software
converts the files to
produce a series of
patient specific
molds and converts
the mold files into
STL files for 3D
printed aligners. | Uses a scan of tooth
impression or a
digital scan to
generate the image
of a final treated
state and then
interprets a series of
images that
represent
intermediate teeth
states. The S/W
converts the files to
produce the series of
patient specific
molds which are 3D
printed, so aligners
are vacuum
thermoformed over
the molds. | Uses a scan of tooth
impression or a
digital scan to
generate the image
of a final treated
state and then
interprets a series of
images that
represent
intermediate teeth
states. The S/W
converts the files to
produce the series of
patient specific
molds which are 3D
printed, so aligners
are vacuum
thermoformed over
the molds. | No S/W included |
| Digital Imaging Tools | Software is used as
an aid to diagnosis
and for treatment
planning by the
clinician | Software is used as
an aid to diagnosis
and for treatment
planning by the
clinician | Software is used as
an aid to diagnosis
and for treatment
planning by the
clinician | No S/W included |
| Attribute | Blue Sky Bio Aligner
G & Blue Sky Plan
S/W for Blue Sky Bio
Aligner G | Arcad Aligner
System & Arcad
SmileStudio
(Primary Predicate) | Blue Sky Bio Aligner
(Reference Device) | Tera Harz Clear
(Reference Device) |
| Teeth Segmentation | Segment individual
teeth within the
model to allow
independent digital
movement of the
teeth | Segment individual
teeth within the
model to allow
independent digital
movement of the
teeth | Segment individual
teeth within the
model to allow
independent digital
movement of the
teeth | No S/W included |
| Planning of Orthodontic Treatments | Virtual planning of
orthodontic
treatments
simulating tooth
movements | Virtual planning of
orthodontic
treatments
simulating tooth
movements | Virtual planning of
orthodontic
treatments
simulating tooth
movements | No S/W included |
| Export of Data Format | Export data as
Stereolithography
(STL file format) | Export data as
Stereolithography
(STL file format) | Export data as
Stereolithography
(STL file format) | No S/W included |
| STL File Type | Export STL files of a
layer of a defined
thickness
corresponding to the
negative of a series
of models. The STL
files are intended to
manufacture directly
printed aligners | Export STL files for
printing a series of
models. The models
are to be used as a
basis for
thermoformed
aligners | Export STL files for
printing of a series of
models. The models
are to be used as a
basis for
thermoformed
aligners | 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.