(61 days)
Not Found
No
The summary describes a physical orthodontic bracket made of ceramic material and does not mention any software, algorithms, or data processing capabilities that would indicate the use of AI or ML.
Yes.
The device is intended for use in orthodontic treatment to reposition teeth, which constitutes a therapeutic intervention for a medical condition (malocclusion).
No
Explanation: The device, Avex® CX2 ceramic brackets, is described as being used for orthodontic treatment to re-position teeth. Its function is to facilitate physical changes to the teeth, not to diagnose a condition or disease.
No
The device is described as ceramic brackets made from polycrystalline alumina, which is a physical material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "orthodontic treatment" to "re-position the teeth." This is a mechanical function performed directly on the patient's teeth.
- Device Description: The device is a "ceramic bracket" that is "bonded to teeth" and used with an "orthodontic wire." This describes a physical appliance used for tooth movement.
- Lack of Diagnostic Purpose: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
- Anatomical Site: The anatomical site is "Teeth," which are part of the patient's body, not a specimen.
IVD devices are specifically designed to be used in vitro (outside the body) to analyze biological samples for diagnostic purposes. This device is used in vivo (within the body) for a therapeutic purpose (tooth movement).
N/A
Intended Use / Indications for Use
Avex® CX2 ceramic brackets are intended for use in orthodontic treatment.
Product codes (comma separated list FDA assigned to the subject device)
NJM
Device Description
Avex® CX2 ceramic brackets are intended to be bonded to teeth upon which an orthodontic wire is placed in a slot to re-position the teeth to desired positions. Avex CX2 ceramic brackets are manufactured from polycrystalline alumina (ceramic) material and have a base which has been designed to provide adhesion to the tooth, yet allow for removal when necessary. The raw material has been documented to be biocompatible for its intended contact and duration of contact. There are several other products in the market that have the same indications as these products and the proposed modification does not affect composition, intended use, or indications for use. Opal Orthodontics has followed design control processes outlined in 21 CFR 820.30 and internal procedures to complete our design control procedure and documentation for the Avex CX2.
Avex CX2 ceramic brackets are esthetically preferred as ceramic colored arch wires are available and the vision of "metal mouth" is no longer the case for the bracket wearer. These ceramic brackets and certain arch wires are intended to match natural tooth coloring in order to reduce visibility.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Avex CX2 ceramic brackets are indicated for use in patients of all ages when prescribed by a dentist or orthodontist.
Intended User / Care Setting
Dental or Orthodontic professional
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)
Avex CX2 has been tested for bond strength, de-bond evaluations, and adhesive shear strength evaluation and met all other design inputs. The Avex CXi₂ has been tested for bond strength, de-bond evaluations, and adhesive shear strength evaluation and met all other design inputs. The comparative results of the testing demonstrated that the modified Avex CX2 is substantially equivalent to the predicate, Avex CX2 and Avex CXi2.
No clinical performance testing was performed on Avex CX2, ceramic brackets.
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.
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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 25, 2015
Opal Orthodontics By Ultradent Products Marie Hess Sr. Regulatory Affairs Associate 505 West 10200 South South Jordan, Utah 84095
Re: K152779
Trade/Device Name: Avex Cx2 Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: II Product Code: NJM Dated: October 13, 2015 Received: October 15, 2015
Dear Ms. Marie Hess:
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.
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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 contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Susan Runno DDS, mA
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K152779
Device Name Avex CX2
Indications for Use (Describe)
Avex® CX2 ceramic brackets are intended for use in orthodontic treatment.
Opal Orthodontics by Ultradent Products, Inc. 505 West 10200 South South Jordan, UT 84095
Form Approvedi, QMB4N07889120-0120
Expiration Date: January 31, 2017
See PRA Statement below.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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K152779
Section 5: Special 510(k) Summary
This summary of the Special 510(k) substantial equivalence information is being submitted in accordance with the requirements of 21 CFR 807.92.
l. Applicant's Name and Address
Opal Orthodontics by Ultradent Products, Inc. 505 West 10200 South South Jordan, UT 84095
| Contact Person: | Ms. Marie Hess |
|---|---|
| Title: | Sr. Regulatory Affairs Associate |
| Telephone: | 800-552-5512 x4610, 801-553-4610 |
| FAX: | 801-553-4609 |
Date Summary Prepared:
22 September, 2015
II. Name of the Device
| Trade Name: | Avex® CX2 |
|---|---|
| Common Name: | Ceramic Bracket |
| Device Classification: | Class II |
| Classification Product Code: | NJM |
| Regulation No. | 21 CFR 872.5470 |
III. Predicate Device:
Avex CX2, ceramic brackets are a modification of Avex CX2, cleared under 510(k) K113334, also manufactured by Opal Orthodontics by Ultradent Products. Avex CX2 and Avex CXi2 are made from polycrystalline alumina (ceramic). They come in two prescriptions; McLaughlin and Opal R, with two slot sizes; .018 and .022. These brackets have the same measurement designators found in all orthodontic brackets such as angle of torque; angulation; in/out; slot height, depth, length; and dimensions of the auxiliary slot. Avex CX₂ is a bracket consisting of only the ceramic material while the Avex CXi2 has a stainless steel metal slot liner to help reduce friction between the material of the bracket in the slot and the arch wire. They are translucent and have the same basic forms as other ceramic brackets like tie wings and hooks so as to facilitate their intended use.
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Indications for use of predicate device:
Avex CX2 and Avex CXi2 ceramic brackets are intended for use in orthodontic treatment.
IV. Device Description of subject device:
Avex® CX2 ceramic brackets are intended to be bonded to teeth upon which an orthodontic wire is placed in a slot to re-position the teeth to desired positions. Avex CX2 ceramic brackets are manufactured from polycrystalline alumina (ceramic) material and have a base which has been designed to provide adhesion to the tooth, yet allow for removal when necessary. The raw material has been documented to be biocompatible for its intended contact and duration of contact. There are several other products in the market that have the same indications as these products and the proposed modification does not affect composition, intended use, or indications for use. Opal Orthodontics has followed design control processes outlined in 21 CFR 820.30 and internal procedures to complete our design control procedure and documentation for the Avex CX2.
Avex CX2 ceramic brackets are esthetically preferred as ceramic colored arch wires are available and the vision of "metal mouth" is no longer the case for the bracket wearer. These ceramic brackets and certain arch wires are intended to match natural tooth coloring in order to reduce visibility.
Avex CX2 ceramic brackets are indicated for use in patients of all ages when prescribed by a dentist or orthodontist.
V. Indications for use of subject device:
Avex CX2 ceramic brackets are intended for use in orthodontic treatment.
VI. Comparison of technological characteristics Avex CX2 and Avex CXi₂, (K113334), and Avex CX2 have similar technological characteristics:
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Table 5-1: Substantial equivalence comparison
| Characteristic | Predicate: Avex CX®2 and Avex®
CXi2, (K113334) | Avex® CX2 |
|--------------------------------------------|----------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|
| Indications for Use | Avex CX2 and Avex CXi2, (K113334) are
intended for use in orthodontic treatment. | Avex CX2 ceramic brackets are
intended for use in orthodontic
treatment. |
| Intended user | Dental or Orthodontic
professional | Dental or Orthodontic professional |
| Material
Characteristics | Polycrystalline alumina (ceramic) | Polycrystalline alumina (ceramic) |
| | Tie wings for ligature wires and
identification marks for
placement | Tie wings for ligature wires and
identification marks for placement |
| Physical Properties | Molded ceramic body with
rounded corners, edges, and
hooks, and physically prepared
base. | Molded ceramic body with rounded
corners, edges, and hooks, and
physically prepared base. |
| | Available in .018 and .022 slot
sizes and various prescriptions | Available in .018 and .022 slot sizes
and various prescriptions |
| Compliance to
applicable
standard(s) | Complies to ISO 27020:2010 | Complies to ISO 27020:2010 |
| Biocompatibility | Device demonstrated through
literature studies to be non-toxic
per ISO 10993-1 | Device demonstrated through
literature studies to be non-toxic per
ISO 10993-1 |
The Avex® CX2 is composed of polycrystalline alumina, which has been widely used by manufacturers in the dental industry for more than 2 decades. The efficacy or
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suitability to the intended purpose of Avex CX2 has been demonstrated by a combination of inhouse testing and side-by-side comparisons to predicate devices currently on the market. Results of our testing document that Avex CX2 is substantially equivalent in performance t o predicate devices currently on the market.
Avex CX2 has been tested for bond strength, de-bond evaluations, and adhesive shear strength evaluation and met all other design inputs. The Avex CXi₂ has been tested for bond strength, de-bond evaluations, and adhesive shear strength evaluation and met all other design inputs. The comparative results of the testing demonstrated that the modified Avex CX2 is substantially equivalent to the predicate, Avex CX2 and Avex CXi2.
No clinical performance testing was performed on Avex CX2, ceramic brackets.
In conclusion, Avex CX2, ceramic brackets, have been designed and manufactured with the intended use and claims for the product in mind. Published literature, bench test data, and risk/benefit reviews have been collected and evaluated to determine substantial equivalence in safety and effectiveness of similar devices and the Avex CX2 bracket for the same indications. Therefore, the modified version Avex CX2, is substantially equivalent to Avex CX2 cleared under K113334.