Who is the manufacturer of Blue Sky Bio Computerized Orthodontic Bracket System?

Blue Sky Bio filed the 510(k) submission for Blue Sky Bio Computerized Orthodontic Bracket System (K182338).

What is the FDA product code for Blue Sky Bio Computerized Orthodontic Bracket System?

DYW. It is classified under 21 CFR 872.5470 as a Class 2 device in the Dental panel.

What is the regulatory pathway for Blue Sky Bio Computerized Orthodontic Bracket System?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like Blue Sky Bio Computerized Orthodontic Bracket System?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Blue Sky Bio Computerized Orthodontic Bracket System

K182338 · Blue Sky Bio · DYW · Nov 9, 2018 · Dental

Device Facts

Record ID	K182338
Device Name	Blue Sky Bio Computerized Orthodontic Bracket System
Applicant	Blue Sky Bio
Product Code	DYW · Dental
Decision Date	Nov 9, 2018
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 872.5470
Device Class	Class 2
Attributes	Software as a Medical Device, 3rd-Party Reviewed

Intended Use

Blue Sky Bio Computerized Orthodontic Bracket System is a software system intended for use as an aid in orthodontic treatment planning to correct malocclusions in orthodontic patients. For use by dental professionals trained in orthodontic treatment, including radiographic analyses and treatment planning. Blue Sky Bio Computerized Orthodontic Bracket System is intended for use with commercially available brackets currently used in standard orthodontic treatment. The end product is an indirect bonding tray for use by the dental professional to place multiple brackets at the same time.

Device Story

Software system aids orthodontic treatment planning; corrects malocclusions. Inputs: dental impressions, 3D models, panoramic X-rays, facial/intra-oral images. Software calculates ideal bracket positions based on clinician-provided treatment plan. Outputs: digital treatment plan for clinician review/adjustment; 3D-printed models with bracket landmarks or 3D-printed indirect bonding trays. Used in dental clinics by orthodontists/dental professionals. Clinician reviews/approves plan; technician bonds brackets into printed landmarks or uses printed tray to place brackets on patient dentition. Facilitates precise bracket placement; improves efficiency of indirect bonding process.

Clinical Evidence

Bench testing only. Accuracy of software-generated bracket placement verified by comparing digitized physical models with software-generated 3D models. All samples met performance criteria. No clinical data presented.

Technological Characteristics

Software-based orthodontic planning system. Utilizes 3D scanning/digitization. Output options: 3D-printed models or 3D-printed indirect bonding trays. Compatible with commercially available orthodontic brackets. Software classified as moderate level of concern.

Indications for Use

Indicated for orthodontic patients requiring malocclusion correction. For use by dental professionals trained in orthodontic treatment, radiographic analysis, and treatment planning.

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

Exceed Computerized Precision Bracket Placement Solution (K151702)

Related Devices

K150702 — Exceed Tx · Great Lakes Orthodontics, Ltd. · Mar 24, 2016
K171634 — Ortho System · 3Shape A/S · Jan 17, 2018
K082207 — ORTHOCAD IQ · Cadent, Inc. · Oct 23, 2009
K192701 — DIBS (Digital Indirect Bonding System) · Orthoselect, LLC · Apr 21, 2020
K152086 — 3Shape Ortho System · 3Shape A/S · Apr 28, 2016

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. Blue Sky Bio % Dave Yungvirt CEO Third Party Review Group, LLC The Old Station House 24 Lackawanna Place Millburn, New Jersey 07041 Re: K182338 Trade/Device Name: Blue Sky Bio Computerized Orthodontic Bracket System Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic plastic bracket Regulatory Class: Class II Product Code: DYW, NJM,ELF Dated: August 22, 2018 Received: August 28, 2018 Dear Dave Yungvirt: 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. November 9, 2018 {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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). | Sincerely, | | |------------|-----------------------------| | Mary S. | Digitally signed by Mary S. | | Runner -S3 | Runner -S3 | | | Date: 2018.11.09 12:38:39 | | | -05'00' | For Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ Section 4 Indications for Use {3}------------------------------------------------ # Indications for Use 510(k) Number (if known) #### Device Name Blue Sky Bio Computerized Orthodontic Bracket System Indications for Use (Describe) Blue Sky Bio Computerized Orthodontic Bracket System is a software system intended for use as an aid in orthodontic treatment planning to correct malocclusions in orthodontic patients. For use by dental professionals trained in orthodontic treatment, including radiographic analyses and treatment planning. Blue Sky Bio Computerized Orthodontic Bracket System is intended for use with commercially available brackets currently used in standard orthodontic treatment. The end product is an indirect bonding tray for use by the dental professional to place multiple brackets at the same time. 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. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {4}------------------------------------------------ # Section 5 510(k) Summary or Statement {5}------------------------------------------------ #### 510(k) Summary # March 26, 2018 ## Blue Sky Bio Computerized Orthodontic Bracket System Blue Sky Bio LLC 888 E Belvidere Rd Suite 212 Grayslake. IL 60030 718-376-0422 www.blueskybio.com Contact Person: Albert Zickmann azickmann@blueskybio.com | General Information | | |---------------------|-----------------------------------------------------------------------------------------------------------------| | Trade Name | Blue Sky Bio Computerized Orthodontic Bracket System | | Common Name | Accessory for orthodontic bracket | | Product Codes | DYW (Orthodontic plastic bracket), NJM (Orthodontic Ceramic Bracket), and ELF (Orthodontic Metal Bracket) | | Regulation No. | 21CFR 872.5470 Orthodontic Plastic Brackets | | Classification | Class II | Page 1 of 5 {6}------------------------------------------------ ## Predicate 510k: Exceed Computerized Precision Bracket Placement Solution K151702 #### Indications for Use: Blue Sky Bio Computerized Bracket System is a software system intended for use as an aid in orthodontic treatment planning to correct Malocclusions in Orthodontic Patients. For use by dental professionals trained in orthodontic treatment, including radiographic analyses and treatment planning. Blue Sky Bio Computerized Orthodontic Bracket System is intended for use with commercially available brackets currently used in standard orthodontic treatment. The end product is an indirect bonding tray for use by the Dental professional to place multiple brackets at the same time. This is identical to the indications for use of the predicate device. #### Device Description: The device consists of proprietary software that calculates the ideal position of the dental brackets based on the dental impressions and or 3D models supplied by the patient's orthodontist. Commercially available brackets are used as part of the system. This is identical to the device description for the predicate device. #### Mode of Operation The operating principle for Blue Sky Bio Computerized Orthodontic Bracket System and the Exceed Computerized Precision Bracket Placement Solution is identical. In addition Blue Sky Bio is also introducing an option to print a model that includes printed brackets. The difference between the two procedures is minor and both procedures yield the same result, a tray with the orthodontic brackets attached to it. The dentist will take the tray and apply a commercially available bonding material to the brackets. Subsequently, the tray with the brackets and the bonding material is placed onto the patient's dentition and the brackets are bonded in the position determined by the tray. The tray is removed. The accuracy of the position of the brackets is then visually inspected in the same manner as with traditional orthodontics. In case, that the position of one or more brackets need to be corrected, the dentist can do that in a traditional manner. The orthodontic treatment is then continued in a traditional fashion. ## Mechanism of Action: The mechanism of action is similar to the predicate devices and supports a determination of substantial equivalence. Orthodontic tooth movement occurs through forces applied to the teeth by the appliance to the dentition as each tooth follows the programmed displacement based on a dental health professional's prescription. Page 2 of 5 {7}------------------------------------------------ #### Performance Testing: Testing was conducted verifying that the treatment plan performed in the software resulted in accurate placement of the brackets and corresponded to the treatment plan in Blue Sky Bio software. The accuracy of data transfer through the software was confirmed by scanning and digitizing physical models and comparing scanned 3D models with the 3D models generated by the treatment plan in the software. All samples met the performance criteria. #### Biocompatibility Testing: The resin used for printing indirect bonding trays is a legally marketed impression tray resin so no testing was performed. The brackets used with the trays are all 510k exempt or 510k cleared devices so no testing was performed. Indirect bonding trays made using pressure forming are made from a 510k cleared or exempted resin so no testing was performed. # Software Verification and Validation Testing: Software verification and validation testing were conducted on the Blue Sky Bio Computerized Orthodontic Bracket System software that allows the user to locate the brackets in order to create an indirect bonding tray and export either the bonding tray or a model to form a bonding tray over. Documentation was provided as recommended by FDA's Guidance for Industry and FDA staff, "Guidance for the Content of Premarket Submission for Software Contained in Medical Devices." The software for this device was considered as a "moderate" level of concern. Page 3 of 5 {8}------------------------------------------------ Predicate Device Comparison Table | | Blue Sky Bio Computerized Orthodontic Bracket System | Exceed Computerized Precision Bracket Placement Solution | |-----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications for Use | Blue Sky Bio Computerized Bracket System is a software system intended for use as an aid in orthodontic treatment planning to correct Malocclusions in Orthodontic Patients. For use by dental professionals trained in orthodontic treatment, including radiographic analyses and treatment planning. Blue Sky Bio Computerized Orthodontic Bracket System is intended for use with commercially available brackets currently used in standard orthodontic treatment. The end product is an indirect bonding tray for use by the Dental professional to place multiple brackets at the same time. | eXceed Computerized Precision Bracket Placement Solution is a software system intended for use as an aid in orthodontic treatment planning to correct Malocclusions in Orthodontic Patients. For use by dental professionals trained in orthodontic treatment, including radiographic analyses and treatment planning. eXceed Computerized Precision Bracket Placement Solution is intended for use with commercially available brackets currently used in standard orthodontic treatment. The end product is an indirect bonding tray for use by the Dental professional to place multiple brackets at the same time. | | Key Records | A 3D model is generated from scanned analog impressions or directly from an intra-oral scan | A 3D model is generated from scanned analog impressions or directly from an intra-oral scan | | Additional Records | A panoramic X-ray, facial and intra- oral images. | A panoramic X-ray, facial and intra- oral images | | Treatment Plan | A detailed treatment plan is provided by the clinician as part of case submission. | A detailed treatment plan is provided by the clinician as part of case submission. | | Virtual Bracket Placement Plan | Using the submitted records and the prescribed treatment plan, a suggested placement plan is generated and sent for review by the clinician. The Clinician utilizes the Blue Sky Bio software to adjust the plan and later have it approved. | Using the submitted records and the prescribed treatment plan, a suggested placement plan is generated and sent for review by the clinician. The Clinician utilizes the eXceed software to adjust the plan and later have it approved. | | Manufacturing | A working pre-treatment model, which includes tooth and bracket-specific landmarks depicting the position of the brackets based on the approved plan, is printed. Brackets are bonded by a technician within the landmarks. Alternatively, the indirect bonding tray is printed. | A working pre-treatment model, which includes tooth and bracket- specific landmarks depicting the position of the brackets based on the approved plan, is printed. Brackets are bonded by a technician within the landmarks. | | Finished Product | Vacuum forming then follows to produce patient- specific indirect bonding trays. Alternatively, the indirect bonding tray is printed. | Vacuum forming then follows to produce patient- specific indirect bonding trays. | Page 4 of 5 {9}------------------------------------------------ # Conclusion: Blue Sky Bio Computerized Orthodontic Bracket System is as safe, as effective, and is substantially equivalent to the predicate device in regards to indications for use, design, technological characteristics, mechanism of action, performance, materials and biocompatibility.