(143 days)
No
The summary describes a 3D-printed orthodontic bracket system and its physical properties and testing. There is no mention of AI or ML in the intended use, device description, or performance studies. The software mentioned is of "Minor Level of Concern," which typically does not involve complex AI/ML algorithms.
Yes.
The device is intended for orthodontic movement of natural teeth by treating malocclusions, which is a therapeutic purpose.
No
The device is described as a bracket system for orthodontic movement of teeth, which is a treatment rather than a diagnostic function.
No
The device description explicitly states it is a "3D-printed bracket system" made of "photopolymer denture resin," indicating it is a physical hardware device, not software only. While software is mentioned for verification and validation, it is in support of the hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide orthodontic movement of natural teeth. This is a direct treatment applied to the patient's body, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The device is a physical bracket system bonded to teeth. It's a therapeutic device, not a diagnostic one.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples (blood, urine, tissue, etc.), reagents, or diagnostic information.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Braces on Demand Bracket is intended for use as a clear, plastic bracket system to provide orthodontic movement of natural teeth.
Product codes (comma separated list FDA assigned to the subject device)
DYW, PNN
Device Description
The proposed device is a 3D-printed bracket system that directly bonds to either primary teeth, permanent teeth, or mixed dentition to provide for orthodontic treatment for patients with malocclusions. Each bracket is 3D printed using a photopolymer denture resin.
The Braces on Demand Bracket System has an integral hook design, which allows for attachment of accessories such as elastics or springs to assist the clinician in producing the desired tooth movement. The hook position on the Braces on Demand brackets can be on the mesial occlusal tiewing or the distal occlusal tiewing, similar to traditional orthodontic brackets.
The application and removal of the Braces on Demand brackets are similar to other orthodontic brackets in that it requires orthodontic adhesive for bonding and standard orthodontic tools and techniques for de-bonding. The bonding surface of the bracket is a mechanical dovetail undercut design, allowing the bracket to mechanically retain the adhesive and bond to the facial surface of the tooth.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
natural teeth
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Dental Professionals trained in orthodontics.
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)
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.
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.
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.
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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
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Indications for Use
510(k) Number (if known)
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) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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K201940 510(k) Summary
| Submitter Name: | Braces on Demand, Inc. | |
|---|---|---|
| Submitter Address: | 422 South Broadway, Suite 203 | |
| Hicksville, NY 11801 | ||
| Email Address: | colin.corey@bracesondemand.com | |
| Telephone: | (516) 477-8377 | |
| Contact Person: | Colin Corey | |
| 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 | ||
| 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, | |
| Ortho Specialties, Inc. | K180941, 3Shape Ortho | |
| System™; 3Shape A/S | ||
| Reference Device | K172398, Dentca Denture Teeth, Denterprise International, Inc. | |
| Indications for Use | ||
| Statement: | The Braces on Demand Bracket System is intended for use as | |
| a clear, plastic bracket system to provide orthodontic movement of | ||
| natural teeth. | ||
| Device Description | ||
| and Summary of | ||
| Technological | ||
| Characteristics | The proposed device is a 3D-printed bracket system that directly | |
| bonds to either primary teeth, permanent teeth, or mixed dentition | ||
| to provide for orthodontic treatment for patients with | ||
| malocclusions. Each bracket is 3D printed using a photopolymer | ||
| denture resin. | ||
| The Braces on Demand Bracket System has an integral hook | ||
| design, which allows for attachment of accessories such as | ||
| elastics or springs to assist the clinician in producing the desired | ||
| tooth movement. The hook position on the Braces on Demand | ||
| brackets can be on the mesial occlusal tiewing or the distal | ||
| occlusal tiewing, similar to traditional orthodontic brackets. | ||
| The application and removal of the Braces on Demand brackets | ||
| are similar to other orthodontic brackets in that it requires | ||
| orthodontic adhesive for bonding and standard orthodontic tools | ||
| and techniques for de-bonding. The bonding surface of the | ||
| bracket is a mechanical dovetail undercut design, allowing the | ||
| bracket to mechanically retain the adhesive and bond to the facial | ||
| 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".
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| Brand | Model | Type | |
|---|---|---|---|
| Printing | |||
| Systems: | Formlabs | Form 3 | SLA |
| Formlabs | Form 2 | SLA | |
| Software | |||
| Systems: | Formlabs | PreForm | Printer software |
| Formlabs | Dashboard | Print monitoring software | |
| Post | |||
| Processing | |||
| 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.
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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
(Proposed Device) | Ortho Specialties
(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
Brackets are intended
for use as a clear,
plastic bracket system
to provide orthodontic
movement of natural
teeth. | The Composite Brackets
are intended for use as a
clear, plastic bracket
system to provide
orthodontic movement of
natural teeth. | Indicated for the same
purpose – movement
of teeth. |
| Target Users | Dental Professionals
trained in orthodontics. | Dental Professionals
trained in orthodontics. | Same |
| Appliance
Material | Biocompatible plastic,
photopolymer | Biocompatible plastic,
polycarbonate | Same category of
biocompatible plastic.
Difference in
manufacturing method
– Braces on Demand
photopolymer is meant
for 3D Printing and the
Ortho Specialties
polycarbonate is
meant for injection
molding. |
| Features | Clear (translucent tooth
tone) bracket system | Clear (translucent)
bracket system | Both brackets systems
offer an aesthetic
treatment option, the
Braces on Demand
system is more tooth
tone with some
transparency, the
Ortho Specialties is
more transparent with
some minor white
coloring |
Table A Substantial Equivalence Summary - Predicate A
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| Mode of use | Archwire
implementation by
dental professional's
technique | Archwire implementation
by dental professional's
technique | Same |
|-------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Physical
Properties | Mechanical Retention
base eliminated need for
plastic condition pre-
treatment. Tooth
position printed on
bracket for
identification. | Mechanical Retention
base eliminated need for
plastic condition pre-
treatment. Non-toxic ink
on brackets for
identification. | Same mechanical
retention base. Tooth
position identification
is directly printed into
the part with Braces
on Demand brackets,
eliminating the need
for ink dots. |
| Application | Bonded | Bonded | Same |
| Manufacturing
Method | 3D Printed | Molded, thermoformed | Braces on Demand
brackets utilize an
additive manufacturing
process (3D Printing)
to create the finished,
isotropic shape layer
by layer. The Ortho
Specialties Bracket
utilized plastic injection
molding to transform
the molten plastic into
the final desired
shape. |
Table B Substantial Equivalence Summary – Predicate B
| Element | Braces on Demand
Bracket
(Proposed Device) | 3Shape
Ortho System
(Predicate Device) | Comparison |
|-----------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Company | Braces on Demand
Inc. | 3Shape Inc. | N/A |
| 510(k) | To be Assigned | K180941 | N/A |
| Indications for
Use | The Braces on
Demand Brackets are
intended for use as a
clear, plastic bracket
system to provide
orthodontic
movement of natural
teeth. | Ortho System™ for
dental retainers and
dental cast for sequential
aligners 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 appliance design
options based on 3D
models of the patient's
dentition before the start
of an orthodontic
treatment. | The 3Shape system is
designed around using
removable clear
aligners, whereas the
Braces on Demand
system is designed
around using direct
bonded appliances
(brackets). Both
systems utilize tools to
manage appliances,
and fabricate said
appliances using 3D
printers with STL file
formats. |
| Target Users | Dental Professionals
trained in
orthodontics. | Dental Professionals
trained in orthodontics. | Same |
| | | | |
| Appliance
Material | Medical grade
plastic,
photopolymer | Medical grade plastic,
thermoformed (K062828) | Same category of
medical plastic.
Difference in
manufacturing method
– Braces on Demand
photopolymer is meant
for 3D Printing and the
3Shape aligner
material is meant for
thermoforming after a
3D printed model is
created. |
| Features | Clear (translucent
tooth tone) bracket
system | Clear (translucent)
removable retainer | Both systems offer an
aesthetic treatment
option, the Braces on
Demand system is
direct bonded to the
tooth while the 3Shape
system is removable. |
| Mode of use | Computer
Application, for
clinician to specify
and design the
medical device for
manufacturing | Computer Application,
for the clinician to specify
and design the series of
medical devices for
manufacturing | Similar applications,
the difference is in the
nature of direct bonded
appliances of Braces
on Demand vs. the
removable clear
aligners of 3Shape |
| Physical
Properties | Direct bonded
appliance. | Removable appliance
does not require any
bonding. | Different method of
action, the direct
bonded appliance of
Braces on Demand vs.
the removable clear
aligner of 3Shape. |
| Virtual planning
of orthodontic
treatments
simulating tooth
movements | No | Yes | No simulated tooth
movement is
necessary for
traditional direct
bonded appliances. |
| Stereolithography
(STL file format) | Yes | Yes | Same |
| Manufacturing
Method | 3D Printed | 3d Printed, then
thermoformed | Braces on Demand
brackets utilize an
additive manufacturing
process (3D Printing)
to create the finished,
isotropic shape layer
by layer.
The 3Shape
Ortho System utilizes
3D printing of models,
and subsequent
thermoforming to
create the sequential
clear aligners. |
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