(90 days)
No
The device description and performance studies focus on the mechanical properties and function of a physical orthodontic bracket system, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes.
The device is intended to aid in the movement of teeth during orthodontic treatment, which is a therapeutic purpose.
No
Explanation: The device is an orthodontic ceramic bracket system intended to aid in the movement of teeth, which is a treatment function, not a diagnostic one.
No
The device description clearly states it is a "system of aesthetic passive self-ligating brackets" which are physical components bonded to teeth. The performance studies also focus on physical properties like bond strength and structural integrity.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "aid in the movement of teeth during orthodontic treatment." This is a direct treatment of the patient's physical structure (teeth).
- Device Description: The device is a system of brackets bonded directly to the patient's teeth. This is a physical appliance used within the body.
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. This device does not involve the examination of such specimens.
The Clear21™ orthodontic ceramic bracket system is a medical device used for orthodontic treatment, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Clear21™ orthodontic ceramic bracket system is intended to aid in the movement of teeth during orthodontic treatment.
Product codes (comma separated list FDA assigned to the subject device)
NJM
Device Description
The Clear21™ orthodontic ceramic bracket system from World Class Technology Corporation is a system of aesthetic passive self-ligating brackets for fixed appliance orthodontic treatment. The brackets are bonded directly to patient's teeth of the maxillary arch. The self-ligating mechanism (i.e. the door) eliminates the need for elastomeric and steel ligatures. The system is intended for use with clinician chosen orthodontic auxiliary devices.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
maxillary arch
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Dental professionals trained in orthodontic treatment / Orthodontic Clinic Use
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)
Non-Clinical Testing - The application includes detailed discussions of nonclinical testing. In all instances, the Clear21 bracket device preformed as intended. Biocompatibility testing was also performed, demonstrating that the bracket materials and processing are acceptable based on the contact category for the Clear21 brackets. Functional testing was done to compare the Clear21 bracket's performance to that of its predicate and reference devices. A reference device, the Carriere SLX bracket, was used to compare the bond strength performance of the Clear21 bracket. The predicate device incorporates a unique proprietary bond base and the reference device uses a bond base design similar to the Clear21 and is more consistent with typical bond base designs. The ligation mechanism, structural integrity and bond strength of the Clear21 bracket are similar to the predicate and reference devices, as demonstrated through the results of functional testing. The Clear21 bracket produces similar results for ligating door open/close force range values, door pull-out, rotational strength, hook strength and bond strength. The nonclinical evaluations provide evidence of the Clear21 bracket's safety and effectiveness when used as intended.
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.
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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November 12, 2019
World Class Technology Corporation % Alyssa Thomas Principal Consultant Allegiance Regulatory Consulting LLC 16642 SW Lansford Ct. Beaverton, Oregon 97007
Re: K192202
Trade/Device Name: Clear21 Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: Class II Product Code: NJM Dated: August 9, 2019 Received: August 14, 2019
Dear Alyssa Thomas:
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 medical devices and radiation-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,
for Srinivas Nandkumar, Ph.D. Acting Director DHT1B: Division of Dental 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) K192202
Device Name
Clear21TM
Indications for Use (Describe)
The Clear21™ orthodontic ceramic bracket system is intended to aid in the movement 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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This summary of 510(k) information is being submitted in accordance with the requirements of SMDA (Safe Medical Devices Act) 1990 and 21 CFR 807.92.
The assigned 510(k) number is: K192202
5.1. Submitter Contact Information
| Name: | World Class Technology Corporation |
|---|---|
| Address: | 1300 NE Alpha Drive |
| McMinnville, OR 97128, USA | |
| Phone: | 503-472-8320 |
| Fax: | 503-435-2432 |
| Contact: | Alan Kozlowski |
| Date Prepared: | November 11, 2019 |
5.2. Device Identification
| Trade Name: | Clear21™ |
|---|---|
| Common Name: | Orthodontic Ceramic Bracket |
| Classification Name: | Orthodontic Plastic Bracket |
| Regulatory Class: | 872.5470 |
| Product Code: | NJM |
5.3. Legally Marketed Predicate Device(s)
Predicate Device: K081415 Ormco Corporation's Damon 4Clear (currently marketed as "Damon Clear" and "Damon Clear2")
Reference Device: K173440 Ortho Organizers, Incorporated/Henry Schein Orthodontics' Carriere SLX 3D Clear
5.4. Device Description
The Clear21™ orthodontic ceramic bracket system from World Class Technology Corporation is a system of aesthetic passive self-ligating brackets for fixed appliance orthodontic treatment. The brackets are bonded directly to patient's teeth of the
4
maxillary arch. The self-ligating mechanism (i.e. the door) eliminates the need for elastomeric and steel ligatures. The system is intended for use with clinician chosen orthodontic auxiliary devices.
5.5. Intended Use/Indications for Use
The Clear21™ orthodontic ceramic bracket system is intended to aid in the movement of teeth during orthodontic treatment.
5.6. Summary of Technological Characteristics
The Clear21 bracket system includes brackets designed to provide the aesthetic benefit of clear ceramic materials with the function of traditional metal brackets. The brackets are available for the upper maxillary teeth from the second bicuspid to the second bicuspid, i.e. 5 to 5. The bracket body and door are ceramic injection molded. The threecomponent bracket assembly includes the bracket body, door and a spring. The Clear21 bracket is similar in materials, design, manufacturing processes and principles of operation as the predicate device (Damon Clear2). There are no significant differences between the Clear21 device and the predicate. A table comparing the key features of the subject device and the predicate device is provided below (Table 5-1Table 5-1).
| | Clear21
(Subject Device) | Damon Clear / Damon
Clear2
(K081415) |
|--------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer /
Marketing Company | World Class Technology
Corporation | Ormco Corporation |
| Intended Use /
Indication for Use | The Clear21™ orthodontic
ceramic bracket system is
intended to aid in the
movement of teeth during
orthodontic treatment. | The Damon 4Clear* is a
ceramic bracket system
intended to aid in the
movement of patient teeth
during orthodontic
treatment.
- Name at the time of submission |
| Clinical Application | Orthodontic Treatment | Orthodontic Treatment |
| Clinical Setting / Site
of Use | Prescription Device for
Orthodontic Clinic Use | Prescription Device for
Orthodontic Clinic Use |
| | Clear21 | Damon Clear / Damon
Clear2
(K081415) |
| | (Subject Device) | |
| Target User | Dental professionals trained
in orthodontic treatment | Dental professionals trained
in orthodontic treatment |
| | Technology Characteristics | |
| Device Materials | Polycrystalline Alumina &
Nitinol | Polycrystalline Alumina &
Nitinol |
| Device Design | Three-component
construction comprised of a
ceramic door & body with a
nitinol spring element. The
spring provides force for the
ligating mechanism | Three-component
construction comprised of a
ceramic door & body with a
nitinol spring element. The
spring provides force for the
ligating mechanism |
| Bracket Base Design | Base designed for direct
bonding to the facial surface
of the teeth. The bracket
bonding pad/base includes
mechanical retention
features that are formed in
the ceramic material | Base designed for direct
bonding to the facial surface
of the teeth. The bracket
bonding pad/base utilizes
mechanical retention
features that are laser cut
into the ceramic material |
| Bracket Hook Feature | Select brackets include an
integrated hook for
accessory attachment | Select brackets include an
integrated hook for
accessory attachment |
| Ligation Method | Self-Ligating | Self-Ligating |
| Bracket Identification | Color-coded Dots | Color-coded Dots |
| Manufacturing Method | - Ceramic Injection Molded
- Processed Pad/Base
- Spring Cut from Flat
Stock - Component Assembly | - Ceramic Injection Molded
- Laser-Etch Pad/Base
- Spring Formed into a
Tubular Split Pin - Component Assembly |
| Functional Dimension (Prescription) | | |
| In-Out | 0.0265" - 0.0385" | 0.03" - 0.040" |
| Torque | -11 deg. through +12 deg. | -11 deg. through +22 deg. |
| Angulation | 2 to 9 deg. | 2 to 9 deg. |
| Rotation | None of the brackets in the
system incorporate rotation | None of the brackets in the
system incorporate rotation |
| | Clear21 | Damon Clear / Damon
Clear2 |
| | (Subject Device) | (K081415) |
| Principles of Operation | | |
| Mode of Use | An archwire, selected by the
clinician, is inserted into the
archwire slots in the
brackets and the ligating
door is closed, securing the
archwire in the slot. The
archwires provide the forces
needed to move the teeth in
accordance with the dental
professional's goals and
technique. | An archwire, selected by the
clinician, is inserted into the
archwire slots in the
brackets and the ligating
door is closed, securing the
archwire in the slot. The
archwires provide the forces
needed to move the teeth in
accordance with the dental
professional's goals and
technique. |
| Application | Bracket pad/base is directly
bonded to the facial surface
of the tooth using typical
orthodontic adhesives and
bonding techniques | Bracket pad/base is directly
bonded to the facial surface
of the tooth using typical
orthodontic adhesives and
bonding techniques |
Table 5-1 Subject & Predicate Device Comparison
5
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5.7. Performance Data
Non-Clinical Testing - The application includes detailed discussions of nonclinical testing. In all instances, the Clear21 bracket device preformed as intended. Biocompatibility testing was also performed, demonstrating that the bracket materials and processing are acceptable based on the contact category for the Clear21 brackets. Functional testing was done to compare the Clear21 bracket's performance to that of its predicate and reference devices. A reference device, the Carriere SLX bracket, was used to compare the bond strength performance of the Clear21 bracket. The predicate device incorporates a unique proprietary bond base and the reference device uses a bond base design similar to the Clear21 and is more consistent with typical bond base designs. The ligation mechanism, structural integrity and bond strength of the Clear21 bracket are similar to the predicate and reference devices, as demonstrated through the results of functional testing. The Clear21 bracket produces similar results for ligating door open/close force range values, door pull-out, rotational strength, hook strength and bond strength. The nonclinical evaluations provide evidence of the Clear21 bracket's safety and effectiveness when used as intended.
7
Clinical Testing - Clinical testing is not included in this submission
5.8. Substantial Equivalence
The Clear21 brackets are as safe and effective as the predicate, the Damon Clear2. The Clear21 bracket system has the same indications for use as the predicate device. Clear21 has similar technological characteristics and principles of operation as its predicate device. The minor technological differences between the Clear21 brackets and its predicate device raise no new or different issues of safety or effectiveness, as evident by the comparison testing. The performance data demonstrates that the Clear21 brackets are as safe and effective as the Damon Clear/Clear2 brackets. Thus, the Clear21 is substantially equivalent.
5.9. Conclusions
Conclusions drawn from the comparison to the predicate device and the nonclinical testing demonstrate that the Clear21 ceramic bracket system is as safe, as effective, and performs as well as the predicate device.