(56 days)
Not Found
No
The device description and performance studies focus on the physical and mechanical properties of a restorative material, with no mention of AI or ML technologies.
No.
The device is a restorative material for direct dental restorations, not a therapeutic device designed to treat a disease or condition.
No
The device description indicates that it is a restorative material used for direct restorations and corrections of tooth position and shape, not for diagnosing conditions.
No
The device description clearly states it is a "light-cure, radiopague restorative material," which is a physical substance, not software. The performance studies also focus on physical and mechanical properties according to ISO standards for restorative materials.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended uses listed are all related to direct dental restorations and repairs performed in the mouth (intraorally). IVDs are used to examine specimens from the human body (like blood, urine, tissue) outside the body (in vitro) to provide information for diagnosis, monitoring, or screening.
- Device Description: The description clearly states it's a "light-cure, radiopaque restorative material" used for filling cavities and restoring teeth. This is a material applied directly to the patient's teeth, not a test performed on a sample.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, performing tests on specimens, or providing diagnostic information based on laboratory results.
The device is a dental restorative material, which falls under a different category of medical devices than IVDs.
N/A
Intended Use / Indications for Use
Indications for Use:
- Direct restorations for all cavity classes in anterior and posterior teeth
- Direct veneers
- Correction of tooth position and tooth shape (e.g. diastema closure, dwarfed tooth, etc.)
- Intraoral repairs of fractured restorations
Product codes
EBF
Device Description
The subject device, CLEARFIL MAJESTY ES-2, is a light-cure, radiopague restorative material which provides accurate color matching, high polishability and excellent physical properties, making it ideal for both anterior and posterior restorations. It is formulated with optimal viscosity assuring easy handling and placement. It is packaged in traditional svringes or Pre-loaded tips (PLTs). The lightness/ value based unique shade taking system of its Shade guide provides shade taking options for single (Classic) and dual (Premium) shade lavering for highly esthetic restorations.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
anterior and posterior teeth
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)
Physical and mechanical properties of the subject device are evaluated according to ISO 4049: 2009 (Dentistry - Polymer-based restorative materials). According to ISO 4049: 2009, the subject device is classified into the following:
- Type 1: Polymer-based restorative materials;
- Class 2: materials whose setting is effected by light;
- Group 1: materials whose use requires the energy to be applied intra-orally.
The subject device complies with all requirements of ISO 4049: 2009 as polymer-based restorative materials.
Regarding the comparison with the predicate device according to ISO 4049: 2009, the subject device and the predicate device comply with ISO 4049: 2009 indicating that the subject device is substantially equivalent in safety and effectiveness to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3690 Tooth shade resin material.
(a)
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.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image contains a sequence of handwritten digits. The digits appear to be '1212158.3'. The numbers are written in a simple, somewhat crude style, with varying stroke thicknesses. The digits are closely spaced, and the overall impression is that of a quickly jotted down number.
[CLEARFIL MAJESTY ES-2, Kuraray Noritake Dental Inc.] Section 3: Summary
Date:
510(k) Summary
3-1. 510(k) owner (submitter) 1) Name
-
Address
-
Contact person
-
Contact person in U.S.
Kuraray Noritake Dental Inc.
1621 Sakazu. Kurashiki, Okayama 710-0801. Japan
Michio Takigawa · Quality Assurance Department
Kiyoyuki Arikawa KURARAY AMERICA INC. 33 Maiden Lane, 6th Floor, New York, NY 10038 Tel: (212)-986-2230 (Ext. 115) or (800)-879-1676 Fax: (888)-700-5200
3-2. Name of Device 1) Trade / Proprietary name
-
Classification name
-
Common name
CLEARFIL MAJESTY ES-2
Tooth shade resin material (21 CFR section 872.3690. Product code: EBF)
Dental light-cured restorative composite
3-3. Predicate device 1) CLEARFIL MAJESTY Esthetic
2) CLEARFIL MAJESTY Flow
510(k) Number: Product Code: 21 CFR Section: Applicant: Inc.
K061860 EBF 872.3690 Kuraray Noritake Dental
510(k) Number: K063593 Product Code: EBF 872.3690 21 CFR Section: Applicant: Inc.
Kuraray Noritake Dental
JUL 25 2012
1
3-4. Description of device
-
- The subject device, CLEARFIL MAJESTY ES-2, is a light-cure, radiopague restorative material which provides accurate color matching, high polishability and excellent physical properties, making it ideal for both anterior and posterior restorations. It is formulated with optimal viscosity assuring easy handling and placement. It is packaged in traditional svringes or Pre-loaded tips (PLTs).
The lightness/ value based unique shade taking system of its Shade guide provides shade taking options for single (Classic) and dual (Premium) shade lavering for highly esthetic restorations.
- The subject device, CLEARFIL MAJESTY ES-2, is a light-cure, radiopague restorative material which provides accurate color matching, high polishability and excellent physical properties, making it ideal for both anterior and posterior restorations. It is formulated with optimal viscosity assuring easy handling and placement. It is packaged in traditional svringes or Pre-loaded tips (PLTs).
It is intended for the following indications:
[1]Direct restorations for all cavity classes in anterior and posterior teeth
- [2]Direct veneers
- [3]Correction of tooth position and tooth shape (c.g. diastema closure, dwarfed tooth. etc.)
[4]Intraoral repairs of fractured restorations
-
- It is classified into tooth shade resin material (21 CFR section 872.3690, Product code: EBF ) according to 21 CFR § 872 since it is composed of materials such as Bisphenol A diglycidylmethacrylate (Bis-GMA).
-
- Physical and mechanical properties of the subject device are evaluated according to ISO 4049: 2009 (Dentistry - Polymer-based restorative materials). According to ISO 4049: 2009, the subject device is classified into the following:
- Type 1: Polymer-based restorative materials;
- Class 2: materials whose setting is effected by light;
- Group 1: materials whose use requires the energy to be applied intra-orally.
3-5. Substantial Equivalence Discussion
l ) Intended uses
The INDICATIONS of the subject device were written up based on that of the predicate device. Therefore, the intended purposes of the subject device are substantially the same as that of the predicate one.
2) Chemical ingredients / Safety
All chemical ingredients of the subject device are equivalent to those of the predicate devices, CLEARFIL MAJESTY Esthetic and CLEARFIL MAJESTY Flow.
Regarding the predicate devices, there have not been any reported problems or recalls according to the post-market adverse event reporting requirements in the US.
3) Effectiveness / Performance
The subject device complies with all requirements of ISO 4049: 2009 as polymer-based restorative materials.
Regarding the comparison with the predicate device according to ISO 4049: 2009, the subject device and the predicate device comply with ISO 4049: 2009 indicating that the subject device is substantially equivalent in safety and effectiveness to the predicate device.
3-6. Biocompatibility
All the chemical ingredients of the subject device are equivalent to those of the predicate devices. CLEARFIL MAJESTY Esthetic and CLEARFIL MAJESTY Flow.
Regarding the predicate devices, there have not been any reported problems or recalls according to the post-market adverse event reporting requirements in the US. Accordingly, it was considered that the subject device was substantially equivalent in safety to the predicate device.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JUL 25 2012
Kurarav Noritake Dental, Incrporated C/O Mr. Kiyoyuki Arikawa General Manger Kuraray America, Incorporated 33 Maiden Lane, 6th Floor New York, New York 10038
Re: K121583
Trade/Device Name: Clearfil Majesty ES-2 Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Code: EBF Dated: May 28, 2012 Received: May 30, 2012
Dear Mr. Arikawa:
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. 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.
3
Page 2 – Mr. Arikawa
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Antimony A. mart
Anthony D. Watson, B.S., M.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
K 12 1583 510(k) Number (if known):
Device Name: CLEARFIL MAJESTY ES-2
Indications for Use:
-
Direct restorations for all cavity classes in anterior and posterior teeth
-
Direct veneers
-
Correction of tooth position and tooth shape (e.g. diastema closure, dwarfed tooth, etc.)
-
Intraoral repairs of fractured restorations
Over-The-Counter Use Prescription Use イ N/A AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Deyice Evaluation (ODE)
Susan Rummer
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K121583