(29 days)
Not Found
No
The summary describes a composite resin material for dental restorations and does not mention any AI or ML components or functionalities.
No
The device is a restorative composite resin used for direct restorations and corrections of tooth position and shape, which are procedures that restore the body to normal function. These are not considered therapeutic interventions in the medical sense of treating a disease or disorder.
No
Explanation: The device description and intended use indicate it is a restorative composite resin used for repairing and restoring teeth, not for diagnosing conditions.
No
The device description clearly states it is a "restorative composite resin," which is a physical material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended uses listed are for direct restorations, correction of tooth position/shape, and intraoral repairs. These are all procedures performed directly on the patient's teeth within the mouth.
- Device Description: The description details a restorative composite resin used for filling cavities and restoring teeth. This material is applied to the tooth structure.
- Lack of In Vitro Activity: There is no mention of the device being used to examine specimens outside of the body (like blood, urine, tissue samples, etc.) to provide information about a patient's health or condition. IVDs are designed for testing samples in vitro.
The device described is a dental restorative material used for direct clinical application, not for diagnostic testing of biological samples.
N/A
Intended Use / Indications for Use
- Direct restorations for anterior and posterior teeth (Class 1-V cavities)
- Correction of tooth position and tooth shape (e.g. diastema closure, dwarfed tooth, etc.)
- Intraoral repairs of fractured crowns/bridges
Product codes (comma separated list FDA assigned to the subject device)
EBF
Device Description
CLEARFIL MAJESTY Posterior is a light-cure, radiopaque restorative composite resin which provides accurate color matching, high polish ability and excellent physical properties, making it ideal for both anterior and posterior restorations. It is formulated with optimal viscosity assuring casy handling and placement.
All chemical ingredients of the subject device have been used in the predicate device. And the chemical composition of the subject device is very similar to that of the predicate device. Furthermore, physical and mechanical properties of the subject device were evaluated according to ISO 4049 in comparison with the predicate device, in which the similarity between the subject device and the predicate device was shown in terms of effectiveness/performance. Therefore, it was concluded that the subject device was closely similar to the predicate device.
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)
It has been verified that the subject device complies with the requirements of the applicable IDA recognized consensus standard, ISO 4049: 2000 "Dentistry - Polymer-based filling, restorative and luting materials". As to comparison with the predicate device, according to ISO 4049; 2000, both the subject device and the predicate device comply with ISO 4049: 2000, indicating that the subject device is as effective as and performs as well as the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
[CLEARFIL MAJESTY Posterior, KURARAY MEDICAL INC.]
MAR - 5 2010
1400328
Dalc: February 2, 2010
510(k) Summary
3-1. 510(k) owner (submitter) I) Name
-
Address
-
Contact person
-
Contact person in U.S.
KURARAY MEDICAL INC.
1621 Sakazu, Kurashiki, Okayama 710-0801, Japan
Michio Takigawa Quality Assurance Department
Kiyoyuki Arikawa KURARAY AMERICA INC. 600 Lexington Avenue, 26th Floor New York, NY 10022 Tcl: (212)-986-2230 (Ext. 115) or (800)-879-1676 Fax: (212)-867-3543
3-2. Name of Device
-
Trade / Proprietary name
-
Classification name
-
Common name
-
Device Listing number
3-3. Predicate device
- CLEARFIL MAJESTY Postcrior
CLEARFIL MAJESTY Posterior Tooth shade resin material (21 CFR section 872.3690. Product code: EBF) Restorative composite resin 12001413
| 510(k) Number: | K063595 |
|---|---|
| Classification: | Tooth shade resin material |
| Product Code: | EBF |
| 21 CFR Section: | 872.3690 |
| Applicant: | KURARAY MEDICAL INC |
1
3-4. Device Description
CLEARFIL MAJESTY Posterior is a light-cure, radiopaque restorative composite resin which provides accurate color matching, high polish ability and excellent physical properties, making it ideal for both anterior and posterior restorations. It is formulated with optimal viscosity assuring casy handling and placement.
All chemical ingredients of the subject device have been used in the predicate device. And the chemical composition of the subject device is very similar to that of the predicate device. Furthermore, physical and mechanical properties of the subject device were evaluated according to ISO 4049 in comparison with the predicate device, in which the similarity between the subject device and the predicate device was shown in terms of effectiveness/performance. Therefore, it was concluded that the subject device was closely similar to the predicate device.
3-5. Similarities and/or differences Discussion
1) Intended uses
The intended uses of the subject device are the same as those of the predicate device.
- Direct restorations for anterior and posterior tecth (Class 1 V cavities) (1)
- (2) Correction of tooth position and tooth shape (c.g. diastema closure, dwarfed tooth, etc.)
- Intraoral repairs of fractured crowns/bridges (3)
2) Chemical ingredients / Safety
The chemical composition of the subject device is very similar to that of the predicate device, suggesting that the safety of the subject device is closely similar to the predicate device. Furthermore, the safety of the predicate device has been shown in the original application. Therefore, we have concluded that the subject device was biologically safe.
3) Effectiveness / Performance
It has been verified that the subject device complies with the requirements of the applicable IDA recognized consensus standard, ISO 4049: 2000 "Dentistry - Polymer-based filling, restorative and luting materials". As to comparison with the predicate device, according to ISO 4049; 2000, both the subject device and the predicate device comply with ISO 4049: 2000, indicating that the subject device is as effective as and performs as well as the predicate device.
2
3-6. Biocompatibility
All chemical ingredients of the subject device are the same as those of the predicate device as described in 7-4. From this fact, it can be said that the safety of the subject device is closely similar to the predicate device. Furthermore, we have already shown the biocompatibility of the predicate device in the original application. Additionally, the predicate device has been sold for 2 years and there were no reported problems or recalls according to the post market adverse event reporting requirement. Therefore, it was concluded that the subject device was biologically safe.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
MAR ~ 5 2010
Kuraray Medical, Incorporated C/O Mr. Kiyoyuki Arikawa Kuraray America, Incorporated 600 Lexington Avenue, 26th Floor New York, New York 1002
Re: K100328
Trade/Device Name: CLEARFIL MAJESTY Posterior Regulation Number: 21CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Code: EBF Dated: February 2, 2010 Received: February 8, 2010
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.
4
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,
h for
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
5
Indications for Use
1400328 510(k) Number (if known):
Device Name: _CLEARFIL MAJESTY Posterior
Indications for Use:
- Direct restorations for anterior and posterior teeth (Class I - V cavities)
-
- Correction of tooth position and tooth shape (e.g. diastema closure, dwarfed tooth, etc.)
- Intraoral repairs of fractured crowns/bridges
Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use _ N/A (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| RSBetz DDS for Dr. K.P. Mulry | |
|---|---|
| (Division Sign-Off) | |
| Division of Anesthesiology, General Hospital | |
| Infection Control, Dental Devices | |
| 510(k) Number: | K100328 |