DynaFlex ® EZ-Align® Appliance is a series of up to four, clear, lightweight, plastic retainers intended to be used to correct minor (1.5mm or less to inter canine/cusped crowding) anterior tooth misalignment in patients in permanent dentition by moving teeth progressively to a final, treated state. DynaFlex EZ-Align® is for prescription only.

Device Description

The device will be custom made for each patient and will be sold by prescription. The device is manufactured with medical grade thermo plastic that is standard throughout the industry.

Aligners are fabricated from .030 thermoformed polycarbonate plastic. The mechanism of force application to the teeth is via intentional distortion of the plastic as the aligners are seated in the mouth. Each subsequent aligner in the overall progressive series is made from a mold of the patient's teeth which reflect subtle changes in the position of the teeth from the previous aliener. The positional changes are introduced into each aligner in the laboratory by moving the teeth on the construction model and then forming the aligner on the same model. The overall treatment is prescribed by the dentist to the laboratory where they are fabricated.

Aligners may be adjusted by the dentist. Aligners are completely removable by the patient and treatment may be discontinued at any time. The appliance if provided as a non-sterile device and single use.

AI/ML Overview

The DynaFlex® EZ-Align® device is a series of clear, lightweight, plastic retainers designed to correct minor anterior tooth misalignment. The available documentation does not describe a study with explicit acceptance criteria or reported device performance metrics in the way one might expect for an AI/CADe device. Instead, the submission focuses on demonstrating substantial equivalence to already legally marketed devices.

Here's a breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

No specific quantitative acceptance criteria (e.g., minimum accuracy, sensitivity, or specificity thresholds) or device performance metrics (e.g., success rates of tooth movement) are stated in the document.

The "Performance Characteristics" section explicitly states: "Bench testing of the Aligners has not been performed due to the difficulty in evaluating this type of dental device in a laboratory setting. However, there is sufficient information available from the scientific literature & other legally FDA cleared device of similar characteristics to demonstrate that the preformed tooth positioner provides reasonable assurance of safety and effectiveness."

Instead of performance metrics against acceptance criteria, the document relies on comparing the device's technological characteristics and intended use to predicate devices. The implicit acceptance criterion is that the device is substantially equivalent to the predicate devices, thereby ensuring comparable safety and effectiveness.

The table below summarizes the comparison of characteristics for substantial equivalence. While not "performance," these are the aspects evaluated for acceptance.

Characteristic	DynaFlex® EZ-Align®	ALLESEE ORTHODONTIC APPLIANCES (RED, WHITE & BLUE®)	Specialty Appliances Works, Inc. (Clear Image™Aligners)	ClearCorrect, Inc. (ClearCorrect™)
Intended Use	Correct minor (1.5mm or less) anterior tooth misalignment in patients with permanent dentition by moving teeth progressively.	Correct minor to intermediate anterior tooth mal-alignments in patients with permanent dentition by moving teeth progressively.	Treating a patient's anterior teeth, involving relatively minor orthodontic tooth movements.	Treatment of tooth malocclusion in patients with permanent dentition.
Mechanism of Action	Basic mechanics follow conventional orthodontics; aligners apply simple force to produce tipping, rotation, extrusion, and intrusion forces (extrusive force limited).	Basic mechanics follow conventional orthodontics; aligners apply simple force to produce tipping, rotation, extrusion, and intrusion forces (extrusive force limited).	Basic mechanics follow conventional orthodontics; aligners apply simple force to produce tipping, rotation, extrusion, and intrusion forces (extrusive force limited).	Basic mechanics follow conventional orthodontics; aligners apply simple force to produce tipping, rotation, extrusion, and intrusion forces (extrusive force limited).
Material	Thermoformed polycarbonate (Plastic)	Thermoformed polycarbonate (Plastic)	Thermoformed polycarbonate (Plastic)	Thermoformed polycarbonate (Plastic)
Sterility	No	No	No	No
Single Use (Patient)	Yes (i.e., multiple use by the same patient)	Yes (i.e., multiple use by the same patient)	Yes (i.e., multiple use by the same patient)	Yes (i.e., multiple use by the same patient)
Worn at Night	Yes	Yes	Yes	Yes
Patient Population	Patient with Permanent Dentition	Patient with Permanent Dentition	Patient with Permanent Dentition	Patient with Permanent Dentition

2. Sample Size Used for the Test Set and Data Provenance

No specific test set or clinical study demonstrating device performance is described. The submission relies on scientific literature and the established safety and effectiveness of predicate devices. Therefore, these details are not applicable.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable, as no described test set or ground truth establishment process is provided. The evaluation is based on a comparison of device characteristics rather than a clinical outcome study requiring expert-derived ground truth.

4. Adjudication Method

Not applicable, as no described test set or adjudication process is provided.

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. This device is a sequential aligner for physical tooth movement, not an AI/CADe product intended to assist human readers (e.g., radiologists) in diagnostic tasks.

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

Not applicable. This device is a physical orthodontic appliance, not an AI algorithm. Its function inherently involves human intervention (dentist prescription, patient use).

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable. The basis for acceptance is "substantial equivalence" to predicate devices, focusing on materials, design, intended use, and mechanism of action, rather than a direct performance evaluation against a defined ground truth for a specific medical outcome. The "ground truth" in this context is the regulatory acceptance of the predicate devices.

8. The sample size for the training set

Not applicable, as this is not an AI/ML device requiring a training set.

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

Not applicable, as this is not an AI/ML device requiring a training set.

Summary of the Study that Proves the Device Meets the Acceptance Criteria:

The "study" presented is a substantial equivalence comparison to legally marketed predicate devices. The manufacturer, DynaFlex, did not conduct a new clinical trial or bench testing to establish the superior or equivalent performance of the EZ-Align® device in terms of clinical outcomes (e.g., percentage of successful tooth alignment).

Instead, they demonstrated substantial equivalence by detailing how the EZ-Align® device shares the same:

Intended Use: Correcting minor anterior tooth misalignment in patients with permanent dentition (with specific thresholds for crowding).
Technological Characteristics: Made from thermoformed polycarbonate plastic, custom-fabricated, non-sterile, single-patient multiple-use, worn at night, and applies force through intentional distortion of the plastic.
Mechanism of Action: Basic mechanics follow conventional orthodontics, applies simple force for tipping, rotation, extrusion, and intrusion (with limited extrusive force).
Materials: Thermoformed polycarbonate.
Patient Population: Patients with permanent dentition.

The submission argues that because these key characteristics are "essentially identical" to those of multiple FDA-cleared predicate devices (Allesee Orthodontic Appliance Inc. - Red, White & Blue (K040874), Specialty Appliance Works, Inc. - Clear Image™ Aligner (K071970), and Clear Correct, Inc. - Clear Correct (K082556)), the EZ-Align® device can be presumed to be as safe and effective as those existing devices. The FDA's 510(k) clearance confirms this finding of substantial equivalence.

Summary

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K121396

AUG 1 4 2012

P.O. Box 99 St. Ann, Missouri 63074 Office 314.426.4020 Fax 314.429.7575 WWW.DYNAFLEX.COM

510(k) Summary

Submitter:

DynaFlex 10403 International Plaza Dr. St. Ann, MO 63074

Contact:

Matthew Malabey Quality & Regulatory DynaFlex 314-426-4020- Phone 314-429-7575-Fax

May 7th, 2012 Date Summary Prepared:

Device Name:

Trade Name EZ-Align® .
. Classification name - Sequential Aligner
. Regulation Description - Orthodontic plastic bracket
Definition - The device moves by gentle force for treatment of minor tooth malocclusion
Regulation Medical Specialty Dental .
Review Panel - Dental
. Product Code - NXC
Regulation Number 21 CFR§ 872.5470 .
. Device Class - 2

Devices for Which Substantial Equivalence is Claimed (Predicated Devices):

. Allesee Orthodontic Appliance Inc. - Red, White & Blue (K040874)
Specialty Appliance Works, Inc .- Clear Image™ Aligner (K071970) .
Clear Correct, Inc .- Clear Correct (K082556) ●

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K121396

Image /page/1/Picture/1 description: The image shows the logo for DynaFlex, a company that provides orthodontic solutions. The logo consists of a black square with a white abstract design on the left, followed by the word "DynaFlex" in bold, black letters. Below the company name is the text "Your Total Orthodontic Solution!" with the superscripted letters SM.

P.O. Box 99 St. Ann, Missouri 63074 Office 314.426.4020 Fax 314.429.7575 WWW.DYNAFLEX.COM

Device Description:

The device will be custom made for each patient and will be sold by prescription. The device is manufactured with medical grade thermo plastic that is standard throughout the industry.

Statement of Intended Use:

DynaFlex ® EZ-Align® Appliance is a series of up to four, clear, lightweight, plastic retainers intended to be used to correct minor (1.5mm or less to inter canine/cusped crowding) anterior tooth misalignment in patients in permanent dentition by moving teeth progressively to a final. treated state. DynaFlex EZ-Align® is for prescription only.

Summary of Technological Characteristics:

Section 5.0: 510(k) Summary Submitter: DynaFlex® EZ-Align® Premarket Notification: Traditional 510(k): A dental health care professional (e.g. Orthodontist or Technological dentist), prescribes the EZ-Align® system based on an characteristics assessment of the patient's teeth, determines a course of treatment with the system, takes molds of the patient's teeth, and completes a prescription form The molds and prescription are sent to Dynaflex designs a series of plastic trays intended to gradually realign the patient's teeth in accordance with the physician's prescription. DynaFlex produces the trays, which are fabricated from .030 thermoformed polycarbonate plastic. The mechanism of force application to the teeth is via intentional distortion of the plastic as the aligners are seated in the mouth. Each subsequent aligner in the overall progressive series is made from a mold of the patient's teeth which reflect subtle changes in the position of the teeth from the previous aligner. The positional changes are introduced into each aligner in the laboratory by moving the teeth on the construction model and then forming the aligner on the same model. The overall treatment is prescribed by the dentist to

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Image /page/2/Picture/1 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, which is written in a bold, sans-serif font. Below the company name is the tagline "Your Total Orthodontic Solution!" in a smaller font size. The "R" and "SM" symbols are present, indicating registered and service mark status, respectively.

P.O. Box 99 St. Ann, Missouri 63074 Office 314.426.4020 Fax 314.429.7575 WWW.DYNAFLEX.COM

the laboratory where they are fabricated. This technology is essentially identical to that used by a number of sequential alignment systems, including the predicates referenced above.

Performance Characteristics:

Bench testing of the Aligners has not been performed due to the difficulty in evaluating this type of dental device in a laboratory setting. However, there is sufficient information available from the scientific literature & other legally FDA cleared device of similar characteristics to demonstrate that the preformed tooth positioner provides reasonable assurance of safety and effectiveness. Biocompatibility testing was performed according to ISO 10993 and that all testing passed.

Substantial Equivalence:

DynaFlex® EZ-Align® is substantially equivalent to other FDA approved legally marketed orthodontic devices in the United States. EZ-Align® Aligners is used in a manner similar to the Clear Image TM system marketed by Specialty Appliance Works, Inc., and Align Technology Red, White & Blue marketed by Allesee Orthodontic Appliances., and Clear Correct marketed by Clear Correct, Inc. The proposed and predicate devices are of similar design; made from virtually identical materials, and are fabricated using similar manufacturing methods that are common to the dental device industry. Furthermore, DynaFlex® EZ-Align® Appliance have the same intended uses as the predicate devices in that they serve as an oral appliance constructed of polymer components that when fabricated into their final form and dimensions, are a dental appliance that are custom fit for the patient. The properties and characteristics of the predicate devices are compared to DynaFlex® EZ-Align® Devices in the Table 12-1.

Table 12-1Substantial Equivalence Comparison
Manufacturer:	DynaFlex®	ALLESEEORTHODONTICAPPLIANCES	SpecialtyAppliancesWorks, Inc.	ClearCorrect, Inc.
Trade Name:	EZ-Align®	RED, WHITE & BLUE®	Clear Image™Aligners	ClearCorrect™
Product Images:	Image: DynaFlex aligners	Image: Allese Orthodontic Appliances	Image: Specialty Appliances Works aligners	Image: ClearCorrect aligners
Product Code:	NXC	NXC	NXC	NXC
Attach Mechanism:(lower to upper tray)	None	None	None	None
Regulation Number:	872.5470	872.5470	872.5470	872.5470

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K121386

Image /page/3/Picture/1 description: The image shows the logo for DynaFlex, a company that provides orthodontic solutions. The logo consists of a black square with white curved lines on the left, followed by the word "DynaFlex" in bold black letters. Below the company name is the text "Your Total Orthodontic Solution!" with a small "SM" symbol next to it.

P.O. Box 99 St. Ann, Missouri 63074 Office 314.426.4020 Fax 314.429.7575 WWW.DYNAFLEX.COM

Regulation Name:	Orthodontic plastic bracket	Orthodontic plastic bracket	Orthodontic plasticbracket	Orthodontic plastic bracket
510(k):	TBD	K040874	K071970	K082556
Statement of IntendedUse:	DynaFlex ® EZ-Align®Appliance is a series of up tofour, clear, lightweight, plasticretainers intended to be usedto correct minor (1.5mm orless to inter canine/cuspedcrowding) anterior toothmisalignment in patients inpermanent dentition bymoving teeth progressively toa final, treated state.DynaFlex EZ-Align® is forprescription only.	ALLESEE ORTHODONTICAPPLIANCES: Red, While &Blue Is a series of three,clear. lightweight, plasticretainers intended to beused to correct minor tointermediate anterior toothmal-alignments in patientswith permanent dentition(second molars) by movingteeth progressively to a final,treated state. The Dentistmakes final decision andadjustment per treatment plan	Specialty Appliances'Clear ImageTM Alignersprimarily are directedtoward treating apatient's anterior teeth.Such treatment involvesthe relatively minororthodontic toothmovements intended toimpact a patient'sappearance and selfimage. The Dentistmakes final decisionand adjustment pertreatment plan	The CearCorrect Systemis indicated for thetreatment of toothmalocclusion in patientswith permanentdentition (i.e. all secondmolars). The ClearCorrectSystem,positions teeth by way ofcontinuous gentle force.The Dentist makes finaldecision and adjustmentper treatment plan
Mechanism of Action:	Basic mechanics follows thesame principles ofconventional orthodontics.The aligners apply a simpleforce on the tooth. Therefore,the Sequential aligners canproduce tipping, rotation,extrusion and intrusion forces.However, the extrusive forcefrom the Sequential Retainersis limited.	Basic mechanics follows thesame principles ofconventional orthodontics.The aligners apply a simpleforce on the tooth. Therefore,the Sequential aligners canproduce tipping, rotation,extrusion and intrusionforces. However, theextrusive force from theSequential Retainers islimited.	Basic mechanics followsthe same principles ofconventionalorthodontics. Thealigners apply a simpleforce on the tooth.Therefore, theSequential aligners canproduce tipping,rotation, extrusion andintrusion forces.However, the extrusiveforce from theSequential Retainers islimited.	Basic mechanics followsthe same principles ofconventional orthodontics.The aligners apply asimple force on the tooth.Therefore, the Sequentialaligners can producetipping, rotation, extrusionand intrusion forces.However, the extrusiveforce from the SequentialRetainers is limited.
Materials:
Stainless Steel:	None	None	None	None
Dental Plastic:	Thermoformed polycarbonate(Plastic)	Thermoformed polycarbonate(Plastic)	Thermoformedpolycarbonate (Plastic)	Thermoformedpolycarbonate (Plastic)
Dimensions:	Various(see Engineering Drawings)	Various(Not available)	Various(Not available)	Various(Not available)
Supplied Sterile:	No	No	No	No
Single Use:	Yes(i.e., multiple use by the samepatient)	Yes(i.e., multiple use by the samepatient)	Yes(i.e., multiple use by thesame patient)	Yes(i.e., multiple use by thesame patient)
Worn at Night:	Yes	Yes	Yes	Yes
Patient Population	Patient with PermanentDentition	Patient with PermanentDentition	Patient with PermanentDentition	Patient with PermanentDentition
Physical Properties	Plastic Sheets/Proprietary	Plastic Sheets/Proprietary	PlasticSheets/Proprietary	Plastic Sheets/Proprietary

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three overlapping wings, symbolizing health, services, and people. The eagle is enclosed within a circle, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference of the circle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

DYNA FLEX Mr. Matthew Malabey Quality & Regulatory Manager 10403 International Plaza Drive St. Ann, Missouri 63074

Re: K121396

Trade/Device Name: DynaFlex® EZ-Align® Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: II Product Code: NXC Dated: May 07, 2012 Received: July 19, 2012

Dear Mr. 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. 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.

AUG 1 4 2012

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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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Nh for

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Image /page/6/Picture/0 description: The image contains the logo for "DynaFlex", a company that provides orthodontic solutions. The logo consists of a stylized graphic to the left of the company name, with the registered trademark symbol next to it. Below the company name is the tagline "Your Total Orthodontic Solution!" with the service mark symbol next to it.

P.O. Box 99 St. Ann, Missouri 63074 Office 314.426.4020 Fax 314.429.7575 WWW.DYNAFLEX.COM

SECTION 4-INDICATION FOR USE

510(k) Number (if known):_

Device Name:

DynaFlex ® EZ-Align®

Indications for Use:

Prescription Use _ X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

Susan Runner

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K121394

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.