Dental Braces (Model: HK-Y-0.4, HK-Y-0.45, HK-Y-0.63, HK-Y-0.7, HK-Y-ST-0.76, HK-Y-CF-0.76, HK-Y-0.9, HK-Y-1.0, HK-Y-2.0)

K230237 · Hkable 3D Biologic Printing Technology(Chongqing) Co., Ltd. · MQC · Sep 14, 2023 · DE

Device Facts

• Record ID: K230237
• Device Name: Dental Braces (Model: HK-Y-0.4, HK-Y-0.45, HK-Y-0.63, HK-Y-0.7, HK-Y-ST-0.76, HK-Y-CF-0.76, HK-Y-0.9, HK-Y-1.0, HK-Y-2.0)
• Applicant: Hkable 3D Biologic Printing Technology(Chongqing) Co., Ltd.
• Product Code: MQC · DE
• Decision Date: Sep 14, 2023
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

The Dental Braces are indicated for the fabrication of orthodontic and dental appliances, such as Orthodontic Appliances, Orthodontic Retainers, Mouth Guards and Splints.

Device Story

Dental Braces are orthodontic materials used by dental professionals to fabricate custom dental appliances. The device serves as a structural component for creating orthodontic retainers, mouth guards, and splints. It is intended for prescription use in a clinical or laboratory setting. The device facilitates the mechanical correction or protection of teeth by providing the necessary material base for appliance construction.

Indications for Use

Indicated for use in the fabrication of orthodontic and dental appliances, including orthodontic appliances, retainers, mouth guards, and splints. Prescription use only.

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The text logo has the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

September 14, 2023

Hkable 3D Biologic Printing Technology (Chongqing) Co., Ltd. % Cassie Lee Manager Guangzhou Glomed Biological Technology Co., Ltd. 2231, Building 1, Rui Feng Center, Kaichuang Road Huangpu District Guangzhou, Guangdong CHINA

Re: K230237

Trade/Device Name: Dental Braces (Model: HK-Y-0.4, HK-Y-0.45, HK-Y-0.63, HK-Y-0.7, HK-Y-ST-0.76, HK-Y-CF-0.76, HK-Y-0.9, HK-Y-1.0, HK-Y-2.0)

Regulatory Class: Unclassified Product Code: MQC, KMY Dated: June 14, 2023 Received: June 16, 2023

Dear Cassie Lee:

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 mediation-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.

## Michael E. Adjodha -S

Michael E. Adjodha, M.ChE. Assistant Director DHT1B: Division of Dental and ENT 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) K230237

Device Name

Dental Braces (Model: HK-Y-0.4, HK-Y-0.63, HK-Y-0.7, HK-Y-ST-0.76, HK-Y-CF-0.76, HK-Y-0.9, HK-Y-1.0, HK-Y-2.0)

Indications for Use (Describe)

The Dental Braces are indicated for the fabrication of orthodontic and dental appliances, such as Orthodontic Appliances, Orthodontic Retainers, Mouth Guards and Splints.

| Type of Use (Select one or both, as applicable) | | | | |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------|
| <table border="0"><tr><td><table border="0"><tr><td><div style="float: left;"> <input checked="true" type="checkbox"/> </div> <div style="float: left;">Construction-Related SWPPP Use</div></td></tr></table></td><td><table border="0"><tr><td><div style="float: left;"> <input type="checkbox"/> </div> <div style="float: left;">Post-Construction (Non-MS4) Use</div></td></tr></table></td></tr></table> | <table border="0"><tr><td><div style="float: left;"> <input checked="true" type="checkbox"/> </div> <div style="float: left;">Construction-Related SWPPP Use</div></td></tr></table> | <div style="float: left;"> <input checked="true" type="checkbox"/> </div> <div style="float: left;">Construction-Related SWPPP Use</div> | <table border="0"><tr><td><div style="float: left;"> <input type="checkbox"/> </div> <div style="float: left;">Post-Construction (Non-MS4) Use</div></td></tr></table> | <div style="float: left;"> <input type="checkbox"/> </div> <div style="float: left;">Post-Construction (Non-MS4) Use</div> |
| <table border="0"><tr><td><div style="float: left;"> <input checked="true" type="checkbox"/> </div> <div style="float: left;">Construction-Related SWPPP Use</div></td></tr></table> | <div style="float: left;"> <input checked="true" type="checkbox"/> </div> <div style="float: left;">Construction-Related SWPPP Use</div> | <table border="0"><tr><td><div style="float: left;"> <input type="checkbox"/> </div> <div style="float: left;">Post-Construction (Non-MS4) Use</div></td></tr></table> | <div style="float: left;"> <input type="checkbox"/> </div> <div style="float: left;">Post-Construction (Non-MS4) Use</div> | |
| <div style="float: left;"> <input checked="true" type="checkbox"/> </div> <div style="float: left;">Construction-Related SWPPP Use</div> | | | | |
| <div style="float: left;"> <input type="checkbox"/> </div> <div style="float: left;">Post-Construction (Non-MS4) Use</div> | | | | |

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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