CLEARFIL MAJESTY ES Flow

K191980 · Kuraray Noritake Dental, Inc. · EBF · Nov 18, 2019 · Dental

Device Facts

• Record ID: K191980
• Device Name: CLEARFIL MAJESTY ES Flow
• Applicant: Kuraray Noritake Dental, Inc.
• Product Code: EBF · Dental
• Decision Date: Nov 18, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3690
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

CLEARFIL MAJESTY ES Flow is indicated for the following restorative applications: [1] Direct restorations for all cavity classes, cervical lesions (e.g. root surface caries, v-shape defects), tooth wear, and tooth erosion [2] Cavity base / liner [3] Correction of tooth position and tooth shape (e.g. diastema closure, tooth malformation) [4] Intraoral repair of fractured restorations [5] Cementation of ceramic and composite inlays, onlays and veneers with less than 2mm thickness

Device Story

CLEARFIL MAJESTY ES Flow is a light-cured, radiopaque, flowable restorative composite resin. It is used by dental professionals in clinical settings for direct restorations, cavity lining, tooth shape/position correction, repair of fractured restorations, and cementation of thin ceramic/composite restorations. The material is applied to the tooth structure and cured using a dental curing light. It provides a restorative or adhesive function to improve tooth aesthetics and structural integrity.

Clinical Evidence

Bench testing only.

Technological Characteristics

Light-cured, radiopaque, flowable composite resin. Class II device (21 CFR 872.3690).

Indications for Use

Indicated for direct restorations (all cavity classes, cervical lesions, tooth wear/erosion), cavity base/liner, correction of tooth position/shape (diastema closure, malformation), intraoral repair of fractured restorations, and cementation of ceramic/composite inlays, onlays, and veneers (<2mm thickness).

Regulatory Classification

Identification

Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.

Submission Summary (Full Text)

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November 18, 2019

Kuraray Noritake Dental Inc. Yasujiro Ohara Manager Ote Center Bldg. 7F, 1-1-3, Otemachi Chiyoda-ku. 100-0004 JAPAN

Re: K191980

Trade/Device Name: CLEARFIL MAJESTY ES Flow Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: Class II Product Code: EBF Dated: August 9, 2019 Received: August 21, 2019

Dear Yasujiro Ohara:

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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801; medical device reporting (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 (OS) 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,

for Srinivas Nandkumar, Ph.D. Acting Director DHT1B: Division of Dental 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): K191980

Device Name: CLEARFIL MAJESTY ES Flow

## INDICATIONS:

CLEARFIL MAJESTY ES Flow is indicated for the following restorative applications:

- [1] Direct restorations for all cavity classes, cervical lesions (e.g. root surface caries, v-shape defects), tooth wear, and tooth erosion
- [2] Cavity base / liner
- [3] Correction of tooth position and tooth shape (e.g. diastema closure, tooth malformation)
- [4] Intraoral repair of fractured restorations
- [5] Cementation of ceramic and composite inlays, onlays and veneers with less than 2mm thickness

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

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

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Concurrence of CDRH, Office of Device Evaluation (ODE)