DynaFlex ® Clear Brackets & Buttons is a series of clear, lightweight, ceramic brackets, and buttons. DynaFlex ® Clear Brackets & Buttons are used in the alignment of teeth through orthodontic treatment of misalignment and malocclusion in patients by moving teeth progressively to a final, treated state.

DynaFlex ® Clear Brackets & Buttons are designed to move teeth to improve their alignment. Ceramic brackets are bonded to natural teeth by dental professionals to connect with orthodontic wires to cause tooth movement to a more preferred position. Ceramic brackets are intended for use in affixed to a tooth so that pressure can be exerted on the teeth. Bonding supplies are used to bond the bracket on to a tooth. Ceramic brackets are bonded to natural teeth by dental professionals to connect with orthodontic wires to cause tooth movement to a more preferred position.

DynaFlex ® Clear Brackets & Buttons may be adjusted by the dentist. The appliance is provided as a non-sterile device and is single use. DynaFlex® Clear Bracket & Buttons is for prescription only.

AI/ML Overview

The provided text does not contain information about the acceptance criteria or a study proving the device meets acceptance criteria in the context of an AI/ML device performance study. The document is a 510(k) summary for DynaFlex Clear Brackets & Buttons, which are orthodontic physical devices, not an AI/ML software.

The document discusses performance characteristics based on bench testing for bond strength and other non-clinical performance tests for overall design, biocompatibility, and manufacturing process validation. It then establishes substantial equivalence to a predicate device (Carriere SLX 3D Clear) based on similar design, materials, manufacturing methods, intended use, and similar technological characteristics.

Therefore, many of the requested elements pertaining to AI/ML device performance studies (such as sample sizes for test and training sets, number of experts, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for AI) are not applicable or available in this document.

However, I can extract the relevant information regarding the performance characteristics and the non-clinical testing performed to establish substantial equivalence for this specific medical device.

Here's the information derived from the provided text, focusing on the available details:

1. Table of Acceptance Criteria and Reported Device Performance

Performance Characteristic	Acceptance Criteria (from predicate or internal requirements)	Reported Device Performance
Minimum Bond Strength (N/MPa)	Predicate: 103.7 / 7.63 (implied as benchmark for "within range")	80 / 6.0 (Met minimum specification)
In/Out (dimension)	Predicate: .025" - .046"	.027" - .039" (Within range of predicate)
Torque (dimension)	Predicate: -17° through +17°	-12° through +12° (Within range of predicate)
Angulation (dimension)	Predicate: Up to +9°	Up to +9° (Within range of predicate)
Rotation (dimension)	Predicate: Up to +12°	Up to +5° (Within range of predicate)
Biocompatibility	ISO 10993-1 and its applicable parts	Passed ISO 10993-1 and series
Manufacturing Process Flow Validation	Specifications of technical requirements	Met specifications
Overall Design Performance	Design inputs and specifications	Met design inputs and specifications

2. Sample size used for the test set and the data provenance

Bond Strength Testing: "all samples tested" (specific number not provided).
Other Non-Clinical Testing: Not specified.
Data Provenance: Not specified, but generally, bench test data is generated in-house by the manufacturer.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable as this is not an AI/ML device performance study requiring expert ground truth for image/data interpretation. Performance is based on physical property measurements and adherence to standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. Performance is based on direct measurement against defined physical or material standards, not interpretive human judgments.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable as this is not an AI/ML device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable as this is not an AI/ML device.

7. The type of ground truth used

For bond strength: Quantitative measurement of physical breaking point against a specified minimum.
For other properties (In/Out, Torque, Angulation, Rotation): Quantitative measurement of dimensions and angles against a specified range (derived from the predicate device).
For biocompatibility: Compliance with ISO 10993 series through laboratory testing.
For manufacturing process: Adherence to internal technical specifications and standards.

8. The sample size for the training set

Not applicable as this is not an AI/ML device.

9. How the ground truth for the training set was established

Not applicable as this is not an AI/ML device.

Summary

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Image /page/0/Picture/0 description: The image contains two logos. On the left is the logo for the Department of Health & Human Services - USA, featuring a stylized human figure. To the right is the logo for the U.S. Food & Drug Administration (FDA), with the FDA acronym in a blue square and the full name "U.S. FOOD & DRUG ADMINISTRATION" written in blue text.

June 5, 2023

Dyna Flex Matthew Malabey Director of Operations 8050 Hawk Ridge Trail Lake Saint Louis, Missouri 63367

Re: K230225

Trade/Device Name: DynaFlex Clear Brackets & Buttons Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: Class II Product Code: NJM Dated: February 21, 2023 Received: February 21, 2023

Dear Matthew Malabey:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Michael E. Adjodha -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 Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K230225

Device Name DynaFlex Clear Brackets & Buttons

Indications for Use (Describe)

DynaFlex ® Clear Bracket & Buttons is indicated for alignment of teeth during orthodontic treatment.

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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Image /page/3/Picture/0 description: The image displays the logo for DynaFlex, a company specializing in orthodontic solutions. The logo features a stylized graphic to the left, followed by the company name "DynaFlex" in a bold, red font, with a registered trademark symbol. Below the company name, the tagline "Your Total Orthodontic Solution!" is written in a smaller, dark teal font, with a service mark symbol.

510(k) Summary (K230225)

Submitter:

DynaFlex 8050 Hawk Ridge Trail. Lake St. Louis, MO 63367

Contact:

Matthew Malabey Director of Operations DynaFlex 314-426-4020- Phone 314-429-7575-Fax

Date Summary Prepared: June 1st, 2023

Device Name:

Trade Name DynaFlex Clear Brackets & Buttons .
Classification name Orthodontic Plastic Bracket O
Regulation Medical Specialty Dental 0
o Review Panel - Dental
o Product Code - NJM
. Regulation Number 21 CFR& 872.5470
o Device Class - 2

Devices for Which Substantial Equivalence is Claimed:

0 Primary Predicate: Ortho Organizers (Henry Schein) .- Carriere SLX 3D Clear (K173440)

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Image /page/4/Picture/0 description: The image shows the logo for DynaFlex, a company that provides orthodontic solutions. The logo consists of a stylized red square with a white abstract design on the left, followed by the company name "DynaFlex" in bold, red letters. Below the company name is the tagline "Your Total Orthodontic Solution!" in a smaller, black font.

Device Descrintion:

DynaFlex ® Clear Brackets & Buttons may be adjusted by the dentist. The appliance is provided as a non-sterile device and is single use. DynaFlex® Clear Brackets & Buttons is for prescription only.

Indications for Use:

DynaFlex ® Clear Bracket & Buttons is indicated for alignment of teeth during orthodontic treatment.

Summary of Technological Characteristics:

A dental health care professional (e.g. Orthodontist or dentist), prescribes the Clear Brackets & Buttons based on an characteristics assessment of the patient's teeth. determines a course of treatment with the system. DynaFlex and Buttons all have a bracket body made of ceramic. DynaFlex brackets are self-ligating ceramic door with a nickeltitanium spring mechanism. Orthodontic brackets are affixed to teeth using an orthodontic adhesive. Pressure is exerted on a tooth when the brackets are used in combination with archwires and/or other intraoral modules. The pressure causes tooth movement.

Performance Characteristics:

Bench testing of the clear brackets & buttons was performed. Specifically, bond strength testing was performed to determine the amount of force required to separate the bonded bracket from the tooth. The minimum specification for bond strength was met by all samples tested.

Non-Clinical Performance Testing

As part of demonstrating substantial equivalence to the predicate devices that are subject to this 510/k) submission. DynaFlex completed a number of non-clinical performance tests. The DynaFlex Clear Bracket & Buttons meet all the requirements for overall design,

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Image /page/5/Picture/0 description: The image shows the logo for DynaFlex, a company that provides orthodontic solutions. The logo features a stylized graphic of a bird in flight, followed by the company name in bold, red letters. Below the company name is the tagline "Your Total Orthodontic Solution!" in a smaller, black font.

biocompatibility, and performance results confirming that the design output meets the design inputs and specifications for the device.

The DynaFlex Clear brackets & buttons meet all the testing in accordance with internal requirements, national standards, and international standards to support substantial equivalence of the subject device.

Manufacturing Process Flow validation was performed to ensure that the finished device matches the specification of the technical requirements. The output and specifications were tested and compared. DynaFlex Clear Bracket & Buttons met the specifications of this testing.

DynaFlex has completed biocompatibility testing per ISO 10993-1 and its applicable parts, as appropriate for the Clear Bracket & Buttons contact and duration. The mechanical properties of the clear brackets and buttons have been demonstrated by the manufacturer as appropriate for use with clear brackets.

Substantial Equivalence:

Chevel Creating Comments Company Contraction Come Con-

DynaFlex® Clear brackets & buttons is substantially equivalent to the Carriere SLX 3D (Clear Kl 7 3 440). DynaFlex Clear Bracket & Buttons is used in a manner similar to the Carriere SLX 3D Clear (K173440) system (Primary Predicate) marketed by Ortho Organizers (Henry Schein). The proposed and predicate devices are of similar design; made from similar materials and are fabricated using similar manufacturing methods that are common to the dental device industry.

Furthermore, DynaFlex® Clear Bracket & Buttons have similar intended uses as the predicate devices. Both the predicate and the subject device serve as an oral appliance constructed of same polymer components, which are intended to move teeth.

There are no substantial technical or functional differences between the predicated orthodontic ceramic bracket and the predicate device in terms of design, function. safety and intended use. Both are ceramic.

However, the self-ligating brackets made of polycrystalline alumina in the proposed device are made

with nickel-titanium springs, unlike the stainless-steel springs of the Predicate Device (K173440). Nickel titanium springs in the proposed device can be considered substantially equivalent to the predicate device, as this material presents no additional risks - technologically, and clinically. Therefore, there are no substantial differences between the subject device and predicate device in terms of the spring used.

The properties and characteristics of the predicate devices are compared to DynaFlex● Clear Bracket & Buttons in the Table 5-1.

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Image /page/6/Picture/0 description: The image shows the logo for DynaFlex, a company that provides orthodontic solutions. The logo consists of a red square with a white abstract design on the left, followed by the word "DynaFlex" in red, with a registered trademark symbol. Below the company name is the text "Your Total Orthodontic Solution!" in a smaller, dark green font, with a service mark symbol.

Table 5-1Substantial Equivalence Comparison
Manufacturer:	DynaFlex®	Ortho Organizer (Henry Schein Co, Predicate)	Comparison
Trade Name:	DynaFlex® ClearBrackets & Buttons	Carriere SLX 3D Clear	N/A
Product Images:	Image: DynaFlex Clear Brackets & Buttons	Image: Carriere SLX 3D Clear	N/A
Product Code:	NJM	NJM	Same
Medical Specialty	Dental	Dental	Same
Regulation Number:	872.5470	872.5470	Same
Regulation Name:	Orthodontic plastic bracket	Orthodontic plastic bracket	Same
510(k):	K230225	K173440	N/A
Indications for Use:	DynaFlex® Clear Bracket &Buttons is indicated foralignment of teeth duringorthodontic treatment.	The Carriere SLX 3D Clearorthodontic ceramic bracketsystem is intended to aid inthe movement of teethduringorthodontic treatment	Similar
Design	Archwire slot, tiewings forligature and identificationmarks for placement Hooksfor ligation, for additionaltooth movement Moldedceramic body with roundedcorners and e Slot to holdorthodontic wires edges	Archwire slot, tiewings forligature and identificationmarks for placement Hooksfor ligation, for additionaltooth movement Moldedceramic body with roundedcorners and e Slot to holdorthodontic wires edges	Same
Base:	Mechanical Lock Base	Mechanical Lock Base	Same
In/Out	.027" - .039"	.025" - .046"	Within range ofpredicate
Torque	-12° through + 12°	-17° through +17°	Within range ofpredicate
Angulation	Up to + 9°	Up to + 9°	Within range ofpredicate
Rotation	Up to + 5°	Up to + 12°	Within range ofpredicate
Mode of Use	An archwire (provided byclinician and worn bypatient)is inserted into the deviceand provides the lightorthodontic forces requiredto move teeth per the dentalprofessional's techniqueandtreatment goals.	An archwire (provided byclinician and worn bypatient)is inserted into the deviceand provides the lightorthodontic forces requiredto move teeth per the dentalprofessional's techniqueandtreatment goals.	Same
Application	Bonded with OrthodonticAdhesive	Bonded with OrthodonticAdhesive	Same
Minimum BondStrength (N/MPa)	80/6.0	103.7/7.63	Within range ofpredicate
Supplied Sterile:	No	No	Same

Single Use:	Yes	Yes	Same
Target Users	Dental Professionals trained in orthodontics	Dental Professionals trained in orthodontics	Same
Physical Properties	Polycrystalline Alumina /Nickle-Titanium Alloy	Polycrystalline Alumina /Stainless Steel	Similar
Biocompatibility	Passed ISO 10993-1 andseries	Passed ISO 10993-1 andseries	Same
Material	Polycrystalline (translucent)alumina,	Polycrystalline (translucent)alumina	Same

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Image /page/7/Picture/0 description: The image shows the logo for "DynaFlex", a company that provides orthodontic solutions. The logo features a stylized graphic to the left of the company name, both in red. Below the company name is the tagline "Your Total Orthodontic Solution!" in a smaller, black font.

Substantial Equivalence Conclusion

By definition, a device is substantially equivalent to a predicate device when the device has the same intended use and the same technological characteristics as the previously cleared predicate device. Based on the comparison and analysis above, the DynaFlex Clear Brackets & Buttons is determined to be substantially equivalent to the predicate device.

Regulation Number and Section

§ 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.