(172 days)
Not Found
No
The description focuses on the material and mechanical function of the orthodontic bracket, with no mention of AI/ML in its operation or design process.
Yes
The device is described as an "orthodonic movement of teeth" device that applies pressure to alter tooth position, which aligns with the definition of a therapeutic device designed to treat a medical condition (malocclusion) or restore function.
No
Explanation: The device description states it is intended for "orthodontic movement of teeth" and applies "pressure to the tooth, transmitted through a flexible orthodontics wire, to alter the tooth position." This indicates a therapeutic or corrective function, not a diagnostic one.
No
The device description explicitly states it is a ceramic orthodontic bracket, which is a physical hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for the orthodontic movement of teeth." This is a mechanical action performed on the body, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The device is a ceramic bracket bonded to teeth to apply pressure. This is a physical device used for treatment, not a reagent or instrument used for in vitro testing.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing diagnostic information about a disease or condition
Therefore, the Luce Ceramic Bracket is a medical device used for orthodontic treatment, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
This device is intended for the orthodonic movement of teeth. It 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, Luce Ceramic Bracket, 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 AI203, 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
Not Found
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)
Biocompatibility testing were conducted on the predicate devices, Alpha Pure(K163117). Since the materials, manufacturing process, packaging materials and methods are identical between the subject and predicate devices, the test reports can be leveraged for the subject device. Subject device and the predicate(K163117) are Identical.
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.
Alpha Pure (K163117)
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/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 9, 2020
Luce Castle Co., Ltd. % Joyce Bang-Kwon CEO Provision Consulting Group Inc. 100 N. Barranca St Suite 700 West Covina. California 91791
Re: K201038
Trade/Device Name: Luce Ceramic Bracket Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: Class II Product Code: NJM Dated: July 6, 2020 Received: July 13, 2020
Dear Joyce Bang-Kwon:
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.
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
1
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 'Nandu'' Nandkumar, Ph.D. Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name
Luce Ceramic Bracket
Indications for Use (Describe)
This device is intended for the orthodonic movement of teeth. It 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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510(K) SUMMARY
510(k) Summary - K201038
This 510(k) Summary is being submitted in accordance with requirement of 21 CFR part 807.92
Submitter:
Kyung Joo Kim Luce Castle Co., Ltd. 16. Ojeoncheon-ro. Uiwang. Gyeonggi, South Korea Email:jinwonline@gmail.com
Official correspondent:
Joyce Kwon Provision Consulting Group 100 N. Barranca St. Suite 700, West Covina, CA 91791 Email: Info@provisionfda.com Phone: 1-909-493-3276
Device Information:
Trade/Proprietary Name: Luce Ceramic Bracket Device Common Name: Bracket, Ceramic, Orthodontic Regulation Class: II Product Code: NJM Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Primary Predicate : Alpha Pure (K163117) Date prepared: 10/9/2020
General Description
The proposed device, Luce Ceramic Bracket, 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 AI203, 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.
Indication 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
4
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 | Primary Predicate
Deivce | Substantial
Equivalence
Discussion |
|-----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------|
| Device Name | Luce Ceramic Bracket | Alpha Pure | N/A |
| Manufacturer | Luce castle Co., Ltd. | Luce castle Co., Ltd. | Identical |
| 510(K) Number | K201038 | K163117 | N/A |
| 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. | Identical |
| Material | Aluminum Oxide | Aluminum Oxide | Identical |
| Biocompatibility | Meets the applicable
requirement of ISO
10993 | Meets the applicable
requirement of ISO 10993 | Identical |
| Maxillary Torque (mm) | -21 to +17 | -21 to +17 | Identical |
| Maxillary Angulation | 0-9 | 0-9 | Identical |
| Slot | 0.018", 0.022" | 0.018", 0.022" | Identical |
| Transparency | Half-transparency | Half-transparency | Identical |
| Indication system | Colored-dot | Colored-dot | Identical |
| 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 | Identical |
| Single Use | Yes | Yes | Identical |
| Non-Sterile Packaging | Yes | Yes | Identical |
Non-Clinical Study Performance
Biocompatibility testing were conducted on the predicate devices, Alpha Pure(K163117). Since the materials, manufacturing process, packaging materials and methods are
identical between the subject and predicate devices, the test reports can be leveraged for the subject device. Subject device and the predicate(K163117) are Identical.
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Conclusion
The subject device performs as well as the predicate device listed above in orthodontic treatment and they are designed, manufactured and engineered to be substantially equivalent to the predicate with respect to indications for use, technological characteristics, device design, materials, performance and biocompatibility. Thus, the overall performance of the subjectdevice is expected to be substantially equivalent to the predicate device.