RODIN Palette Naturalizing Kit

K223365 · Belport Company, Inc., Gingi-Pak · EBD · Mar 27, 2023 · Dental

Device Facts

• Record ID: K223365
• Device Name: RODIN Palette Naturalizing Kit
• Applicant: Belport Company, Inc., Gingi-Pak
• Product Code: EBD · Dental
• Decision Date: Mar 27, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3310
• Device Class: Class 2

Indications for Use

Characterization of provisionals. Characterization of direct & indirect composite restorations, acrylic denture base and artificial acrylic teeth. Characterization of C&B composite resin restorations or acrylic resin.

Device Story

RODIN Palette Naturalizing Kit is a dental material system used for the characterization of dental restorations. It is applied by dental professionals in a clinical or laboratory setting to modify the aesthetic appearance of provisional restorations, direct and indirect composite restorations, acrylic denture bases, and artificial acrylic teeth. The kit provides materials that allow the clinician to customize the shade and surface appearance of these dental appliances, facilitating improved aesthetic outcomes for patients requiring restorative dental work.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Coating material for resin fillings (Product Code EBD). The device consists of materials intended for the characterization of dental resin and acrylic surfaces.

Indications for Use

Indicated for the characterization of provisional restorations, direct and indirect composite restorations, acrylic denture bases, and artificial acrylic teeth. For prescription use only.

Regulatory Classification

Identification

A coating material for resin fillings is a device intended to be applied to the surface of a restorative resin dental filling to attain a smooth, glaze-like finish on the surface of the filling.

Submission Summary (Full Text)

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March 27, 2023

Belport Company, Inc., Gingi-Pak Jingtian Peng R&d 4825 Calle Alto Camarillo, California 93012

Re: K223365

Trade/Device Name: RODIN Palette Naturalizing Kit Regulation Number: 21 CFR 872.3310 Regulation Name: Coating Material For Resin Fillings Regulatory Class: Class II Product Code: EBD Dated: January 5, 2023 Received: January 5, 2023

Dear Jingtian Peng:

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 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

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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,

# Bobak Shirmohammadi -S

For 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)

K223365

Device Name RODIN Palette Naturalizing Kit

#### Indications for Use (Describe)

Characterization of provisionals.

Characterization of direct & indirect composite restorations, acrylic denture base and artificial acrylic teeth. Characterization of C&B composite resin restorations or acrylic resin.

| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------|
|-------------------------------------------------|

| <div> <span> <b> </b> </span> <span> ☑ Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> |
|----------------------------------------------------------------------------------------------------------------------|
| <div> <span> <b> </b> </span> <span> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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