(54 days)
Not Found
No
The device description and intended use are for a dental restorative material, and there is no mention of AI or ML in the provided text.
No
The device is a restorative material for dental applications, not designed to treat a disease or medical condition.
No
The device is a restorative material used for direct restorations, cavity base/liner, correction of tooth position and shape, and repair of fractured restorations, which are therapeutic and restorative applications, not diagnostic.
No
The device is a light-cure, flowable, radiopaque restorative material, which is a physical substance, 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 all related to direct dental restorations and repairs within the mouth. This involves treating the tooth itself, not analyzing samples from the body to diagnose a condition.
- Device Description: The description clearly states it's a "light-cure, flowable, radiopaque restorative material." This is a material used for physical repair, not for diagnostic testing.
- Classification: The device is classified as "tooth shade resin material (21 CFR section 872.3690, Product code:EBF)". This classification falls under dental devices, not IVDs.
- Lack of IVD characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information.
Therefore, CLEARFIL MAJESTY ES Flow is a dental restorative material, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The subjest device 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
Product codes (comma separated list FDA assigned to the subject device)
EBF
Device Description
The subject device, CLEARFIL MAJESTY ES Flow is a light-cure, flowable, radiopaque restorative material which provides accurate color matching, high polishability and excellent physical properties, making it ideal for both anterior and posterior restorations.
It is classified into tooth shade resin material (21 CFR section 872.3690, Product code:EBF) according to 21 CFR8872 since it is composed of materials such as methacrylate monomers.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Regarding the comparison with the predicate device according to ISO 4049: 2009, the subject device and the predicate device complied with ISO 4049: 2009 indicating that the subject device was substantially equivalent in effectiveness to the predicate device.
The test results exhibited that the subject device was substantially equivalent in effectiveness and biocompatibility to 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
Section 3: Summary
Date: Feb. , 2013.
KI30371
510(k) Summary
3-1. 510(k) owner (submitter)
-
Name
-
Address
-
Contact person
-
Contact person in US
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: (212)-867-3543
3-2. Name of Device
- Trade / Proprietary name
-
- Classification name
- Common name
3-3. Predicate Device
Tooth shade resin material
CLEARFIL MAJESTY ES Flow
(21 CFR section 872.3690. Product code: EBF)
872.3690
Kuraray Noritake Dental Inc.
Dental light-cured restorative composite
- CLEARFIL MAJESTY Flow 510(k) Number: K063593 Classification: Tooth shade resin material Product Code: EBF 21 CFR Section: · 872.3690 Applicant: Kuraray Noritake Dental Inc. 2) CLEARFIL MAJESTY ES-2 510(k) Number. K121583 Classification: Tooth shade resin material Product Code: EBF
21 CFR Section:
Applicant:
3-4. Device Description
The subject device, CLEARFIL MAJESTY ES Flow is a light-cure, flowable, radiopaque restorative material which provides accurate color matching, high polishability and excellent physical properties, making it ideal for both anterior and posterior restorations.
It is classified into tooth shade resin material (21 CFR section 872.3690, Product code:EBF) according to 21 CFR8872 since it is composed of materials such as methacrylate monomers.
APR 0 9 2013
1
3-5. Statement of Intended Use
The subjest device 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
3-6. Substantial Equivalence Discussion
-
- 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 those of the predicate devices.
- Intended uses
2) Chemical ingredients / Safety
Except for two new ingredients, all ingredients in this product have been used in the predicate devices. Regarding the above predicate devices, there have not been any reported problems or recalls according to the post-market adverse event reporting requirement in the ns.
Two new ingredients have been evaluated referring to ISO 10993 series and ISO 7405. As the result, it was confirmed that these substances were biologically safe.
In conclusion, it can be said that the safety of the subject device is substantially equivalent to that of the predicate devices.
3) Technological characteristics /Effectiveness and Performance
Regarding the comparison with the predicate device according to ISO 4049: 2009, the subject device and the predicate device complied with ISO 4049: 2009 indicating that the subject device was substantially equivalent in effectiveness to the predicate device.
3-7. Biocompatibility
Except for two new ingredients, all ingredients in this product have been used in the predicate devices. Regarding the above predicate devices, there have not been any reported problems or recalls according to the post-market adverse event reporting requirement in the ાંકે.
Two new ingredients have been evaluated referring to ISO 10993 series and ISO 7405. As the result, it was confirmed that these substances were biologically safe.
In conclusion, it can be said that the safety of the substantially equivalent to that of the predicate devices.
Conclusion
The test results exhibited that the subject device was substantially equivalent in effectiveness and biocompatibility to the predicate device.
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a human figure embracing or supporting three abstract shapes, possibly representing health, well-being, or services.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G60 Silver Spring, MD 20993-0002
April 9, 2013
Kuraray Noritake Dental, Incorporated C/O Ms. Kiyoyuki Arikawa Kuraray America, Incorporated 33 Maiden Lane, 6th Floor NEW YORK NY 10038
Re: K130371
Trade/Device Name: CLEARFIL MAJESTY ES Flow Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Code: EBF Dated: February 6, 2013 Received: February 19, 2013
Dear Ms. 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 - Ms. 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 (OS) 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 vours.
Image /page/3/Picture/7 description: The image shows the text "Kwame O. Ulmer - for S FDA". The text is arranged in a way that suggests it might be a heading or title, possibly related to a document or presentation. The word "FDA" is stylized with a unique design.
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Respiratory. Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
KISOSTI 510(k) Number (if known):
Device Name: CLEARFIL MAJESTY ES Flow
Indications for 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
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
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)
| Mary S. Runner -S |
|---|
| Susan Runner, DDSMA |
| 2013.04.02 |
| 13:13:28:04'00' |
| (Division Sign-Off) | |
|---|---|
| Division of Anesthesiology, General Hospital | |
| Infection Control, Dental Devices |
(3087) 510(k) Number: