(97 days)
Not Found
No
The description details a physical appliance fabricated based on manual manipulation of a model and does not mention any software or algorithms that would suggest AI/ML is used in the design or manufacturing process.
Yes.
The device is intended to correct minor anterior tooth misalignment by moving teeth progressively, which is a therapeutic action.
No
The device is described as an appliance used to correct tooth misalignment by moving teeth progressively, and its intended use is for treatment, not for diagnosing a condition or disease.
No
The device description explicitly states it is a series of clear, lightweight, plastic retainers manufactured from medical grade thermo plastic. This indicates a physical, hardware-based medical device, not a software-only one.
Based on the provided information, the DynaFlex ® EZ-Align® Appliance is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- DynaFlex EZ-Align Function: The DynaFlex EZ-Align appliance is a physical device used directly in the mouth to mechanically move teeth. It does not analyze biological samples or provide diagnostic information about a patient's health status.
- Intended Use: The intended use clearly states it's for "correcting minor... anterior tooth misalignment," which is a physical manipulation, not a diagnostic process.
- Device Description: The description details the physical construction and mechanism of action (applying force to teeth), not a method for analyzing biological samples.
Therefore, the DynaFlex EZ-Align Appliance 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 ® 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.
Product codes
NXC
Device Description
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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
anterior tooth
Indicated Patient Age Range
patients in permanent dentition
Intended User / Care Setting
prescription only. (Dental health care professional (e.g. Orthodontist or dentist))
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 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
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) ●
1
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:
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.
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.
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
2
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 12-1
| Substantial Equivalence Comparison | ||||
|---|---|---|---|---|
| Manufacturer: | DynaFlex® | ALLESEE | ||
| ORTHODONTIC | ||||
| APPLIANCES | Specialty | |||
| Appliances | ||||
| Works, 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 |
3
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 plastic
bracket | Orthodontic plastic bracket |
|-------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k): | TBD | K040874 | K071970 | K082556 |
| 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. | ALLESEE ORTHODONTIC
APPLIANCES: Red, While &
Blue Is a series of three,
clear. lightweight, plastic
retainers intended to be
used to correct minor to
intermediate anterior tooth
mal-alignments in patients
with permanent dentition
(second molars) by moving
teeth progressively to a final,
treated state. The Dentist
makes final decision and
adjustment per treatment plan | Specialty Appliances'
Clear ImageTM Aligners
primarily are directed
toward treating a
patient's anterior teeth.
Such treatment involves
the relatively minor
orthodontic tooth
movements intended to
impact a patient's
appearance and self
image. The Dentist
makes final decision
and adjustment per
treatment plan | The CearCorrect System
is indicated for the
treatment of tooth
malocclusion in patients
with permanent
dentition (i.e. all second
molars). The ClearCorrect
System,
positions teeth by way of
continuous gentle force.
The Dentist makes final
decision and adjustment
per treatment plan |
| Mechanism of Action: | Basic mechanics follows the
same principles of
conventional orthodontics.
The aligners apply a simple
force on the tooth. Therefore,
the Sequential aligners can
produce tipping, rotation,
extrusion and intrusion forces.
However, the extrusive force
from the Sequential Retainers
is limited. | Basic mechanics follows the
same principles of
conventional orthodontics.
The aligners apply a simple
force on the tooth. Therefore,
the Sequential aligners can
produce tipping, rotation,
extrusion and intrusion
forces. However, the
extrusive force from the
Sequential Retainers is
limited. | Basic mechanics follows
the same principles of
conventional
orthodontics. The
aligners apply a simple
force on the tooth.
Therefore, the
Sequential aligners can
produce tipping,
rotation, extrusion and
intrusion forces.
However, the extrusive
force from the
Sequential Retainers is
limited. | Basic mechanics follows
the same principles of
conventional orthodontics.
The aligners apply a
simple force on the tooth.
Therefore, the Sequential
aligners can produce
tipping, rotation, extrusion
and intrusion forces.
However, the extrusive
force from the Sequential
Retainers is limited. |
| Materials: | | | | |
| Stainless Steel: | None | None | None | None |
| Dental Plastic: | Thermoformed polycarbonate
(Plastic) | Thermoformed polycarbonate
(Plastic) | Thermoformed
polycarbonate (Plastic) | Thermoformed
polycarbonate (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 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 |
| Physical Properties | Plastic Sheets/Proprietary | Plastic Sheets/Proprietary | Plastic
Sheets/Proprietary | Plastic Sheets/Proprietary |
4
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
5
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
6
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:
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.
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