(183 days)
Not Found
No
The description focuses on the material and mechanical function of ceramic orthodontic brackets, with no mention of AI or ML.
Yes
The device is described as "ceramics orthodontic brackets which are bonded to teeth to apply pressure to the tooth...to alter the tooth position," which is a therapeutic function.
No
This device is for orthodontic movement of teeth, which is a treatment, not a diagnostic, function. It applies pressure to alter tooth position.
No
The device description explicitly states that the device consists of ceramic orthodontic brackets, which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as "for the orthodontic movement of teeth." This is a mechanical action performed directly on the patient's body.
- Device Description: The device is described as ceramic orthodontic brackets bonded to teeth to apply pressure. This is a physical device used for a therapeutic purpose.
- Lack of IVD Characteristics: 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.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) for a mechanical treatment.
N/A
Intended Use / Indications for Use
This device is intended for the orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment has been completed. The devices are intended to be single use only.
Product codes (comma separated list FDA assigned to the subject device)
NJM
Device Description
The proposed device, Alpha Pure, consists of ceramic orthodontic brackets which are bonded to teeth to apply pressure to the tooth, transmitted through a flexible orthodontics wire, to alter the tooth position. The ceramic bracket is produced using Al203, translucent polycrystalline aluminum oxide (99.99%). The brackets are bonded to the teeth with commercially available materials and linked together by "arch wire" that applies steady, gentle pressure to produce desired tooth movement.
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
Not Found
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 Study performance:
The subject device was found to be in compliance with biocompatibility. The standards which have been applied to the biocompatibility study were ISO 10993 Biological evaluation of medical devices Part 1 – Evaluation and testing in the risk management process, Part 4 - Selection of tests of interactions with blood, Part 5 – Tests for in vitro cytotoxicity and Part 10 – Tests for irritation and delayed-type hypersensitivity.
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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is often associated with healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 9, 2017
Koroad America % Joyce Bang President Provision Consulting Group Inc. 3248 Willow Hollow Rd Chino Hills, California 91709
Re: K163117
Trade/Device Name: Alpha Pure Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: Class II Product Code: NJM Dated: March 15, 2017 Received: April 6, 2017
Dear Joyce Bang:
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. Isting 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.
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) 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/ResourcesforYou/Industry/default.htm. 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
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.
Michael J. Ryan -S
for Tina Kiang, Ph.D. Acting 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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Indications for Use
510(k) Number (if known) K163117
Device Name Alpha Pure
Indications for Use (Describe)
This device is intended for the orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment has been completed. The devices are intended to be single use only.
| 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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K163117
510(k) Summary
This 510(k) summary is being submitted in accordance with the requirements of 21 CFR 807.92.
Submitter:
Yeon Jae Lee, President Koroad America, Inc. 895 Dove Street, Suite 300 Newport Beach, CA 92660 Phone: 714-213-6910
Official Correspondent:
Joyce Bang, President Provision Consulting Group, Inc. 3248 Willow Hollow Rd. Chino Hills, CA 91709 Phone: 909-680-8562 Fax: 909-942-2571
Submission Date: 5/04/2017
Submission Type: Traditional 510(k) Trade/Proprietary Name: Alpha Pure Device Common Name: Bracket, Ceramic, Orthodontic Regulation Class: II Product Code: NJM Regulation Number: 21 CFR 872.5470 Predicate Device: Sapphire Ceramic Bracket (K073045)
Device Description:
The proposed device, Alpha Pure, consists of ceramic orthodontic brackets which are bonded to teeth to apply pressure to the tooth, transmitted through a flexible orthodontics wire, to alter the tooth position. The ceramic bracket is produced using Al203, translucent polycrystalline aluminum oxide (99.99%). The brackets are bonded to the teeth with commercially available materials and linked together by "arch wire" that applies steady, gentle pressure to produce desired tooth movement.
Indications for Use:
This device is indicated for the orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment has been completed. The devices are intended to be single use only.
Comparison to Predicate Device(s):
This device is equivalent to the predicate devices in its intended use and technological characteristics, including:
-
- Indications for use
-
- Technological characteristics
-
- Performance properties
Summary of the technological characteristics compared to the predicate device
The subject device is substantially equivalent to the predicate device in its technological characteristics stated in the comparison table provided below.
| Subject device | Predicate | |
|---|---|---|
| Device Name | Alpha Pure | Sapphire Ceramic Bracket |
| Manufacturer | Luce castle Co., Ltd. | Ortho Technology Inc. |
| 510(k) number | N/A | K073045 |
| Indications for Use | This device is indicated for the orthodontic movement of teeth. It is used temporarily and is removed after | This device is indicated for the orthodontic movement of teeth. It is used temporarily and is removed after |
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| orthodontic treatment has been | orthodontic treatment has been | |
|---|---|---|
| completed. The devices are intended to | completed. The devices are intended to | |
| be single use only. | be single use only. | |
| Material | Aluminum Oxide | Aluminum Oxide |
| Biocompatibility | Meets the applicable requirement of | |
| ISO 10993 | Meets the applicable requirement of ISO | |
| 10993 | ||
| Maxillary Torque (mm) | -21 to +17 | -22 to +17 |
| Maxillary Angulation | 0 – 9 | 0 – 11 |
| Slot | 0.018", 0.022" | 0.018", 0.022" |
| Transparency | Half-transparency | Half-transparency |
| Color | White, same as tooth color | White, same as tooth color |
| Indication system | Colored-dot | Colored-dot |
| Design | Tie wings for ligature, Hook, Archwire | |
| Slot, Round home, base and | ||
| identification marks for placement | Tie wings for ligature, Hook, Archwire | |
| Slot, Round home, base and | ||
| identification marks for placement | ||
| Hooks for ligation, for additional tooth | ||
| movement, Molded ceramic body with | ||
| rounded corners and edges, Slot to | ||
| hold orthodontic wires | Hooks for ligation, for additional tooth | |
| movement, Molded ceramic body with | ||
| rounded corners and edges, Slot to hold | ||
| orthodontic wires | ||
| Single Use | Yes | |
| Non-Sterile Packaging | Yes | Yes |
Non-Clinical Study performance
The subject device was found to be in compliance with biocompatibility. The standards which have been applied to the biocompatibility study were ISO 10993 Biological evaluation of medical devices Part 1 – Evaluation and testing in the risk management process, Part 4 - Selection of tests of interactions with blood, Part 5 – Tests for in vitro cytotoxicity and Part 10 – Tests for irritation and delayed-type hypersensitivity.
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Substantial Equivalence Discussion
The subject device is substantially equivalent to the predicate device in it's a variety of characteristics stated in the comparison table provided below.
| Subject device | Predicate | |
|---|---|---|
| Device Name | Alpha Pure | Sapphire Ceramic Bracket |
| Manufacturer | Luce castle Co., Ltd. | Ortho Technology Inc. |
| 510(k) number | N/A | K073045 |
| Indications for Use | This device is indicated for the | |
| orthodontic movement of teeth. It is | ||
| used temporarily and is removed after | ||
| orthodontic treatment has been | ||
| completed. The devices are intended to | ||
| be single use only. | This device is indicated for the | |
| orthodontic movement of teeth. It is | ||
| used temporarily and is removed after | ||
| orthodontic treatment has been | ||
| completed. The devices are intended to | ||
| be single use only. | ||
| Material | Aluminum Oxide | Aluminum Oxide |
| Biocompatibility | Meets the applicable requirement of | |
| ISO 10993 | Meets the applicable requirement of ISO | |
| 10993 | ||
| Maxillary Torque (mm) | -21 to +17 | -22 to +17 |
| Maxillary Angulation | 0 – 9 | 0 - 11 |
| Slot | 0.018", 0.022" | 0.018", 0.022" |
| Transparency | Half-transparency | Half-transparency |
| Color | White, same as tooth color | White, same as tooth color |
| Indication system | Colored-dot | Colored-dot |
| Design | Tie wings for ligature, Hook, Archwire | |
| Slot, Round home, base and | ||
| identification marks for placement | ||
| Hooks for ligation, for additional tooth | ||
| movement, Molded ceramic body with | ||
| rounded corners and edges, Slot to | ||
| hold orthodontic wires | Tie wings for ligature, Hook, Archwire | |
| Slot, Round home, base and | ||
| identification marks for placement | ||
| Hooks for ligation, for additional tooth | ||
| movement, Molded ceramic body with | ||
| rounded corners and edges, Slot to | ||
| hold orthodontic wires | ||
| Single Use | Yes | Yes |
| Non-Sterile Packaging | Yes | Yes |
Substantial Equivalence Comparison Chart and Discussion
Design Comparison:
The subject device and its predicate device both incorporate specific torques, angulations, and distal offset dimensions, along with archwire slots that are designed to accommodate the correct size archwire (typically .018″ or .022″ thick). They both feature tie wing undercut spaces for orthodontic ligatures, have a molded ceramic bracket bodies with rounded corners and edges for patient comfort, and rounded hooks on the tie wings to accommodate ligation during orthodontic treatment. They both have bases that are designed to provide maximum adhesion to the tooth while still allowing for easy and complete removal when necessary. However, there are slight differences on the range of Maxillary Torque and Maxillary Angulation between the subject and the predicate. While the ranges are not identical, these differences are not expected to affect the overall performance of the device since they are still within the range of what is typically observed for orthodontic brackets.
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Material Comparison:
Like its predicate, the subject devices are manufactured from polycrystalline alumina (ceramic) material, which has a well-documented history of biocompatibility within the oral environment. Like its predicate, the subject devices do not incorporate medicinal substances, tissues, or blood products. They are delivered non- sterile to the end user and are intended to be used once by a single patient.
Indications For Use Comparison:
The subject and predicate device have indications for use. They both are indicated for the orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment has been completed. The devices are intended to be single use only.
Conclusion:
The subject device is designed, manufactured and engineered to be substantially equivalent to the predicate with respect to its equivalent indications for use, technological characteristics, device design, materials, performance and biocompatibility. Although there are slight differences in the range of Maxillary Angulation between the subject and predicate devices, they both are within the range of what is typically observed for orthodontic brackets.
Thus, the subject device Alpha Pure is demonstrated to be substantially equivalent to the predicate device.