(129 days)
Not Found
No
The device description and performance studies focus on the physical properties and mechanical performance of ceramic brackets and buttons, with no mention of AI or ML technology.
Yes
The device is used for the "alignment of teeth during orthodontic treatment" and for "moving teeth progressively to a final, treated state," which classifies it as a therapeutic device.
No
Explanation: The device description clearly states that DynaFlex® Clear Brackets & Buttons are "used in the alignment of teeth through orthodontic treatment," "designed to move teeth to improve their alignment," and are "affixed to a tooth so that pressure can be exerted on the teeth." These functions describe a therapeutic or treatment device, not a diagnostic one. There is no mention of the device being used to identify, detect, or monitor a medical condition.
No
The device description explicitly states it is a series of clear, lightweight, ceramic brackets and buttons, which are physical components bonded to teeth. This indicates it is a hardware device, not software-only.
Based on the provided information, the DynaFlex ® Clear Bracket & Buttons is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In vitro diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- DynaFlex ® Clear Bracket & Buttons Function: This device is a physical appliance bonded to teeth to apply force and move them for orthodontic treatment. It directly interacts with the patient's teeth and is used for mechanical alignment, not for analyzing biological specimens.
- Intended Use: The intended use clearly states "alignment of teeth during orthodontic treatment," which is a mechanical process, not a diagnostic one based on biological samples.
- Device Description: The description focuses on the physical properties of the brackets and buttons and how they are used to move teeth. There is no mention of analyzing biological samples.
Therefore, the DynaFlex ® Clear Bracket & Buttons falls under the category of a medical device used for treatment, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
DynaFlex ® Clear Bracket & Buttons is indicated for alignment of teeth during orthodontic treatment.
Product codes (comma separated list FDA assigned to the subject device)
NJM
Device Description
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 Brackets & Buttons is for prescription only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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)
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.
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, 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Minimum Bond Strength (N/MPa): 80/6.0
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.
Not Found
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
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.
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. 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
2
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 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 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 5-1
| Substantial Equivalence Comparison | |||
|---|---|---|---|
| Manufacturer: | DynaFlex® | Ortho Organizer (Henry Schein Co, Predicate) | Comparison |
| Trade Name: | DynaFlex® Clear | ||
| Brackets & 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 for | |||
| alignment of teeth during | |||
| orthodontic treatment. | The Carriere SLX 3D Clear | ||
| orthodontic ceramic bracket | |||
| system is intended to aid in | |||
| the movement of teeth | |||
| during | |||
| orthodontic treatment | Similar | ||
| Design | Archwire slot, tiewings for | ||
| ligature and identification | |||
| marks for placement Hooks | |||
| for ligation, for additional | |||
| tooth movement Molded | |||
| ceramic body with rounded | |||
| corners and e Slot to hold | |||
| orthodontic wires edges | Archwire slot, tiewings for | ||
| ligature and identification | |||
| marks for placement Hooks | |||
| for ligation, for additional | |||
| tooth movement Molded | |||
| ceramic body with rounded | |||
| corners and e Slot to hold | |||
| orthodontic wires edges | Same | ||
| Base: | Mechanical Lock Base | Mechanical Lock Base | Same |
| In/Out | .027" - .039" | .025" - .046" | Within range of |
| predicate | |||
| Torque | -12° through + 12° | -17° through +17° | Within range of |
| predicate | |||
| Angulation | Up to + 9° | Up to + 9° | Within range of |
| predicate | |||
| Rotation | Up to + 5° | Up to + 12° | Within range of |
| predicate | |||
| Mode of Use | An archwire (provided by | ||
| clinician and worn by | |||
| patient) | |||
| is inserted into the device | |||
| and provides the light | |||
| orthodontic forces required | |||
| to move teeth per the dental | |||
| professional's technique | |||
| and | |||
| treatment goals. | An archwire (provided by | ||
| clinician and worn by | |||
| patient) | |||
| is inserted into the device | |||
| and provides the light | |||
| orthodontic forces required | |||
| to move teeth per the dental | |||
| professional's technique | |||
| and | |||
| treatment goals. | Same | ||
| Application | Bonded with Orthodontic | ||
| Adhesive | Bonded with Orthodontic | ||
| Adhesive | Same | ||
| Minimum Bond | |||
| Strength (N/MPa) | 80/6.0 | 103.7/7.63 | Within range of |
| predicate | |||
| 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 and | ||
| series | Passed ISO 10993-1 and | ||
| series | 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.