Luce Ceramic Bracket

K201038 · Luce Castle Co., Ltd. · NJM · Oct 9, 2020 · Dental

Device Facts

• Record ID: K201038
• Device Name: Luce Ceramic Bracket
• Applicant: Luce Castle Co., Ltd.
• Product Code: NJM · Dental
• Decision Date: Oct 9, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.5470
• Device Class: Class 2
• Attributes: Therapeutic

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

Device Story

Luce Ceramic Bracket; ceramic orthodontic brackets bonded to teeth; transmits pressure from arch wire to teeth to alter position; used by orthodontists in clinical settings; ceramic body (99.99% Al2O3) features tie wings, hooks, and archwire slots; provides steady, gentle pressure for tooth movement; removed upon treatment completion.

Clinical Evidence

No clinical data. Bench testing only; biocompatibility testing leveraged from identical predicate device (K163117) per ISO 10993 requirements.

Technological Characteristics

Material: 99.99% translucent polycrystalline aluminum oxide (Al2O3). Design: Molded ceramic body with tie wings, hooks, and archwire slots (0.018", 0.022"). Maxillary torque: -21 to +17; angulation: 0-9. Non-sterile packaging. Single use.

Indications for Use

Indicated for orthodontic tooth movement in patients requiring corrective treatment. Single use only.

Regulatory Classification

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.

Predicate Devices

• Alpha Pure (K163117)

Submission Summary (Full Text)

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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

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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 ([e-mail]) or phone [phone] 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)

K201038

## 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) | |
|----------------------------------------------------------------------------------|----------------------------------------------------------------------|
| <input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) | <input type="checkbox"/> 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:[e-mail]

#### Official correspondent:

Joyce Kwon Provision Consulting Group 100 N. Barranca St. Suite 700, West Covina, CA 91791 Email: [e-mail] Phone: [phone]

#### 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

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## 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<br>Deivce | Substantial<br>Equivalence<br>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<br>for the orthodontic<br>movement of teeth. It is<br>used temporarily and is<br>removed after<br>orthodontic treatment<br>has been completed. The<br>devices are intended to<br>be single use only. | This device is indicated<br>for the orthodontic<br>movement of teeth. It is<br>used temporarily and is<br>removed after orthodontic<br>treatment has been<br>completed. The devices<br>are intended to be single<br>use only. | Identical |
| Material | Aluminum Oxide | Aluminum Oxide | Identical |
| Biocompatibility | Meets the applicable<br>requirement of ISO<br>10993 | Meets the applicable<br>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,<br>Hook, Archwire Slot,<br>Round home, base and<br>identification marks for<br>placement<br>Hooks for ligation, for<br>additional tooth<br>movement, Molded<br>ceramic body with<br>rounded corners and<br>edges, Slot to hold<br>orthodontic wires | Tie wings for ligature,<br>Hook, Archwire Slot,<br>Round home, base and<br>identification marks for<br>placement<br>Hooks for ligation, for<br>additional tooth<br>movement, Molded<br>ceramic body with<br>rounded corners and<br>edges, Slot to hold<br>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.