Braces on Demand Bracket

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December 3, 2020 Braces on Demand, Inc % Patsy Trisler Regulatory Consultant Oserve Group US, Inc. 7949 Beaumont Green East Drive Indianapolis, Indiana 46250 Re: K201940 Trade/Device Name: Braces on Demand Bracket Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: Class II Product Code: DYW, PNN Dated: October 23, 2020 Received: October 28, 2020 Dear Patsy Trisler: 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. 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 {1}------------------------------------------------ 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 medical devices and radiation-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 Adjodha, M.ChE. Assistant Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K201940 Device Name Braces on Demand Bracket Indications for Use (Describe) The Braces on Demand Bracket is intended for use as a clear, plastic bracket system to provide orthodontic movement of natural teeth. | Type of Use (Select one or both, as applicable) | | |----------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------| | <span style="font-size: 10pt;"> <span style="font-family: Symbol;"> </span> Prescription Use (Part 21 CFR 801 Subpart D) </span> | <span style="font-size: 10pt;"> <span style="font-family: Symbol;"> </span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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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." {3}------------------------------------------------ # K201940 510(k) Summary | Submitter Name: | Braces on Demand, Inc. | | |--------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------| | Submitter Address: | 422 South Broadway, Suite 203<br>Hicksville, NY 11801 | | | Email Address: | colin.corey@bracesondemand.com | | | Telephone: | (516) 477-8377 | | | Contact Person: | Colin Corey<br>CEO | | | Date Prepared: | July 8, 2020 | | | Device Trade Name: | Braces on Demand Bracket | | | Common Name | Orthodontic Plastic Bracket, Orthodontic Software | | | | Predicate A | Predicate B | | Predicate Devices<br>Classification Name | Orthodontic Plastic Bracket | Orthodontic Software | | Number | 21 CFR 872.5470 | 21 CFR 872.5470 | | Product Code | DYW | PNN | | Regulatory Class | 2 | 2 | | Predicate Name | K140807, Composite Brackets,<br>Ortho Specialties, Inc. | K180941, 3Shape Ortho<br>System™; 3Shape A/S | | Reference Device | K172398, Dentca Denture Teeth, Denterprise International, Inc. | | | Indications for Use<br>Statement: | The Braces on Demand Bracket System is intended for use as<br>a clear, plastic bracket system to provide orthodontic movement of<br>natural teeth. | | | Device Description<br>and Summary of<br>Technological<br>Characteristics | The proposed device is a 3D-printed bracket system that directly<br>bonds to either primary teeth, permanent teeth, or mixed dentition<br>to provide for orthodontic treatment for patients with<br>malocclusions. Each bracket is 3D printed using a photopolymer<br>denture resin. | | | | The Braces on Demand Bracket System has an integral hook<br>design, which allows for attachment of accessories such as<br>elastics or springs to assist the clinician in producing the desired<br>tooth movement. The hook position on the Braces on Demand<br>brackets can be on the mesial occlusal tiewing or the distal<br>occlusal tiewing, similar to traditional orthodontic brackets. | | | | The application and removal of the Braces on Demand brackets<br>are similar to other orthodontic brackets in that it requires<br>orthodontic adhesive for bonding and standard orthodontic tools<br>and techniques for de-bonding. The bonding surface of the<br>bracket is a mechanical dovetail undercut design, allowing the<br>bracket to mechanically retain the adhesive and bond to the facial<br>surface of the tooth. | | {4}------------------------------------------------ Image /page/4/Figure/2 description: The image is a flowchart outlining the manufacturing process for "The Braces on Demand". The process begins with logging into the software and selecting a device to print, followed by selecting the resin. The flowchart then splits into two paths: "Select Print In-House" and "Order For Deliver", eventually converging at "Add device to cart" and then splitting again into "Buy and Print" and "All manufacturing to be done at the manufacturing facility". {5}------------------------------------------------ | | Brand | Model | Type | |--------------------------------|----------|-----------|---------------------------| | Printing<br>Systems: | Formlabs | Form 3 | SLA | | | Formlabs | Form 2 | SLA | | Software<br>Systems: | Formlabs | PreForm | Printer software | | | Formlabs | Dashboard | Print monitoring software | | Post<br>Processing<br>Systems: | Formlabs | Form Wash | Agitation cleaning system | | | Formlabs | Form Cure | UV post curing system | Equipment and software validated for printing and postprinting processing: Based on a clinician's treatment plan, each bracket is used as Mechanism of Action prescribed to exert the force required for movement of the teeth. Device Testing Laboratory Testing > Bond Strength and Hook Strength testing were performed on the Braces on Demand Bracket System and compared to the predicate device was found to be substantially equivalent. > Dimensional Analysis and Dimensional Stability Tests were performed on the Braces on Demand Bracket System to validate the manufacturing process and prove the design inputs match the manufacturing outputs. > Software verification and validation testing was performed according to FDA's published guidance documents and supporting documents submitted in this 510(k) based on the software being of "Minor Level of Concern". ### Biocompatibility The following ISO 10993 testing was performed according to Good Laboratory Practices to assess the safety and biocompatibility of the plastic material: Part 5 (Cytotoxicity Elution - MEM), The reference device, utilizing the same exact materials and processes, also underwent the following testing: Part 10 (Intracutaneous/Intradermal) Reactivity), Part 10 (Maximization for Delayed-Type Hypersensitivity), Part 11 (Subacute Systemic Toxicity) This testing has shown that the material is safe and biocompatible for the stated intended use. Animal | Human Testing No animal or human testing are required for this product because it is composed of the same materials, is designed similarly, and is manufactured by method similar to the predicate device. {6}------------------------------------------------ Comparison to The Braces on Demand Bracket System, compared to the two Predicate Devices: predicate devices: - . The intended use is the same. - . The mechanisms of action (software and bracket systems) are similar. - I The material used to make the brackets is similar to the predicate and is produced in the same manner (by additive manufacturinq) as the reference device. - I The software used during the manufacturing processes is similar. Based on the documentation presented in the 510(k), as Substantial Equivalence summarized above, it can be concluded that this software system Conclusion and the produced brackets are substantially equivalent to the predicate devices. | Element | Braces on Demand<br>(Proposed Device) | Ortho Specialties<br>(Predicate Device) | Comparison | |-----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Company | Braces on Demand Inc. | Ortho Specialties Inc. | N/A | | 510(k) | To be Assigned | K140807 | N/A | | Indications for Use | The Braces on Demand<br>Brackets are intended<br>for use as a clear,<br>plastic bracket system<br>to provide orthodontic<br>movement of natural<br>teeth. | The Composite Brackets<br>are intended for use as a<br>clear, plastic bracket<br>system to provide<br>orthodontic movement of<br>natural teeth. | Indicated for the same<br>purpose – movement<br>of teeth. | | Target Users | Dental Professionals<br>trained in orthodontics. | Dental Professionals<br>trained in orthodontics. | Same | | Appliance<br>Material | Biocompatible plastic,<br>photopolymer | Biocompatible plastic,<br>polycarbonate | Same category of<br>biocompatible plastic.<br>Difference in<br>manufacturing method<br>– Braces on Demand<br>photopolymer is meant<br>for 3D Printing and the<br>Ortho Specialties<br>polycarbonate is<br>meant for injection<br>molding. | | Features | Clear (translucent tooth<br>tone) bracket system | Clear (translucent)<br>bracket system | Both brackets systems<br>offer an aesthetic<br>treatment option, the<br>Braces on Demand<br>system is more tooth<br>tone with some<br>transparency, the<br>Ortho Specialties is<br>more transparent with<br>some minor white<br>coloring | Table A Substantial Equivalence Summary - Predicate A {7}------------------------------------------------ | Mode of use | Archwire<br>implementation by<br>dental professional's<br>technique | Archwire implementation<br>by dental professional's<br>technique | Same | |-------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Physical<br>Properties | Mechanical Retention<br>base eliminated need for<br>plastic condition pre-<br>treatment. Tooth<br>position printed on<br>bracket for<br>identification. | Mechanical Retention<br>base eliminated need for<br>plastic condition pre-<br>treatment. Non-toxic ink<br>on brackets for<br>identification. | Same mechanical<br>retention base. Tooth<br>position identification<br>is directly printed into<br>the part with Braces<br>on Demand brackets,<br>eliminating the need<br>for ink dots. | | Application | Bonded | Bonded | Same | | Manufacturing<br>Method | 3D Printed | Molded, thermoformed | Braces on Demand<br>brackets utilize an<br>additive manufacturing<br>process (3D Printing)<br>to create the finished,<br>isotropic shape layer<br>by layer. The Ortho<br>Specialties Bracket<br>utilized plastic injection<br>molding to transform<br>the molten plastic into<br>the final desired<br>shape. | ## Table B Substantial Equivalence Summary – Predicate B | Element | Braces on Demand<br>Bracket<br>(Proposed Device) | 3Shape<br>Ortho System<br>(Predicate Device) | Comparison | |-----------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Company | Braces on Demand<br>Inc. | 3Shape Inc. | N/A | | 510(k) | To be Assigned | K180941 | N/A | | Indications for<br>Use | The Braces on<br>Demand Brackets are<br>intended for use as a<br>clear, plastic bracket<br>system to provide<br>orthodontic<br>movement of natural<br>teeth. | Ortho System™ for<br>dental retainers and<br>dental cast for sequential<br>aligners is intended for<br>use as a medical front-<br>end device providing<br>tools for management of<br>orthodontic models,<br>systematic inspection,<br>detailed analysis,<br>treatment simulation and<br>virtual appliance design<br>options based on 3D<br>models of the patient's<br>dentition before the start<br>of an orthodontic<br>treatment. | The 3Shape system is<br>designed around using<br>removable clear<br>aligners, whereas the<br>Braces on Demand<br>system is designed<br>around using direct<br>bonded appliances<br>(brackets). Both<br>systems utilize tools to<br>manage appliances,<br>and fabricate said<br>appliances using 3D<br>printers with STL file<br>formats. | | Target Users | Dental Professionals<br>trained in<br>orthodontics. | Dental Professionals<br>trained in orthodontics. | Same | | | | | | | Appliance<br>Material | Medical grade<br>plastic,<br>photopolymer | Medical grade plastic,<br>thermoformed (K062828) | Same category of<br>medical plastic.<br>Difference in<br>manufacturing method<br>– Braces on Demand<br>photopolymer is meant<br>for 3D Printing and the<br>3Shape aligner<br>material is meant for<br>thermoforming after a<br>3D printed model is<br>created. | | Features | Clear (translucent<br>tooth tone) bracket<br>system | Clear (translucent)<br>removable retainer | Both systems offer an<br>aesthetic treatment<br>option, the Braces on<br>Demand system is<br>direct bonded to the<br>tooth while the 3Shape<br>system is removable. | | Mode of use | Computer<br>Application, for<br>clinician to specify<br>and design the<br>medical device for<br>manufacturing | Computer Application,<br>for the clinician to specify<br>and design the series of<br>medical devices for<br>manufacturing | Similar applications,<br>the difference is in the<br>nature of direct bonded<br>appliances of Braces<br>on Demand vs. the<br>removable clear<br>aligners of 3Shape | | Physical<br>Properties | Direct bonded<br>appliance. | Removable appliance<br>does not require any<br>bonding. | Different method of<br>action, the direct<br>bonded appliance of<br>Braces on Demand vs.<br>the removable clear<br>aligner of 3Shape. | | Virtual planning<br>of orthodontic<br>treatments<br>simulating tooth<br>movements | No | Yes | No simulated tooth<br>movement is<br>necessary for<br>traditional direct<br>bonded appliances. | | Stereolithography<br>(STL file format) | Yes | Yes | Same | | Manufacturing<br>Method | 3D Printed | 3d Printed, then<br>thermoformed | Braces on Demand<br>brackets utilize an<br>additive manufacturing<br>process (3D Printing)<br>to create the finished,<br>isotropic shape layer<br>by layer.<br>The 3Shape<br>Ortho System utilizes<br>3D printing of models,<br>and subsequent<br>thermoforming to<br>create the sequential<br>clear aligners. | {8}------------------------------------------------