(90 days)
Not Found
No
The description focuses on the material composition and physical properties of a dental composite resin, with no mention of AI or ML.
No
The device is described as a restorative composite resin for dental applications, which includes direct restorations, correction of tooth position and shape, and intraoral repairs of fractured crowns/bridges. These uses are structural and cosmetic, rather than therapeutic in nature.
No
Explanation: The device description states it is a light-cure, radiopaque restorative composite resin used for direct restorations, correction of tooth position and shape, and intraoral repairs. It is a material used for treatment, not for diagnosing conditions.
No
The device description clearly identifies the device as a "light-cure, radiopaque 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 use is for direct restorations, correction of tooth position/shape, and intraoral repairs of fractured crowns/bridges. These are all procedures performed directly on the patient's teeth.
- Device Description: The device is described as a light-cure, radiopaque restorative composite resin. This is a material used for filling cavities and restoring tooth structure.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used outside the body to analyze samples. This device is used inside the mouth to restore teeth.
N/A
Intended Use / Indications for Use
-
- Direct restorations for anterior and posterior teeth (Class I V cavities)
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- 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 PLT (PLT:Pre-loaded tip) 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 easy handling and placement. CLEARFIL MAJESTY Posterior PLT, with its special dispensing system, can be quickly and conveniently placed directly into the cavity.
In this application, we have precisely defined the amount of dl-Camphorquinone and N.N-Diethanol-p-toluidine (DEPT) contained in CLEARFIL MAJESTY Posterior PLT in range of chemical composition shown in the original application in order to improve its sensitivity to ambient light. Each of the detailed description is as follows.
Chemical ingredient (weight %)
Predicate device Subject device
dl-Camphorquinone not more than 0.1 0.02
N,N-Diethanol-p-toluidine(DEPT) not more than 0.1 0.10
All chemical ingredients of the subject device have been used in the predicate device. And 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 substantial equivalence between the subject device and the predicate device was shown in terms of effectiveness/performance. Therefore, it was concluded that the subject device was substantially equivalent 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 FDA 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
July 24, 2009 Date:
510(k) Summary
OCT & 7 2009
3-1. 510(k) owner (submitter) 1) Name
- Address
3-2. Name of Device
-
Contact person
-
Contact person in U.S.
-
Trade / Proprietary name
-
Classification name
-
Device Listing number
-
Common name
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 Tel: (212)-986-2230 (Ext. 115) or (800)-879-1676 Fax: (212)-867-3543
CLEARFIL MAJESTY Posterior PLT Tooth shade resin material (21 CFR section 872.3690. Product code: EBF) Restorative composite resin R001413
3-3. Predicate device 1) CLEARFIL MAJESTY Posterior PLT
K071169 510(k) Number: Tooth shade resin material Classification: Product Code: EBF 872.3690 21 CFR Section: KURARAY MEDICAL INC. Applicant:
Quality Assurance Department Ote Center Bldg. 7F, 1-1-3 Otemachi, Chiyoda-ku, Tokyo, 100-0004, Japan Tel : +81.(0)3.6701.1706 Fax : +81.(0)3.6701.1805
1
3-4. Device Description
CLEARFIL MAJESTY Posterior PLT (PLT:Pre-loaded tip) 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 easy handling and placement. CLEARFIL MAJESTY Posterior PLT, with its special dispensing system, can be quickly and conveniently placed directly into the cavity.
In this application, we have precisely defined the amount of dl-Camphorquinone and N.N-Diethanol-p-toluidine (DEPT) contained in CLEARFIL MAJESTY Posterior PLT in range of chemical composition shown in the original application in order to improve its sensitivity to ambient light. Each of the detailed description is as follows.
| Chemical ingredient | (weight %) | |
|---|---|---|
| Predicate device | Subject device | |
| dl-Camphorquinone | not more than 0.1 | 0.02 |
| N,N-Diethanol-p-toluidine | ||
| (DEPT) | not more than 0.1 | 0.10 |
All chemical ingredients of the subject device have been used in the predicate device. And 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 substantial equivalence between the subject device and the predicate device was shown in terms of effectiveness/performance. Therefore, it was concluded that the subject device was substantially equivalent to the predicate device.
3-5. Substantial Equivalence 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 teeth (Class I V cavities) (1)
- Correction of tooth position and tooth shape (e.g. diastema closure, dwarfed (2) tooth, etc.)
- Intraoral repairs of fractured crowns/bridges (3)
-
- 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 substantially equivalent to the predicate device. Furthermore, the safety of the predicate device has been shown in the original application. Therefore, it was 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 FDA 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 An enembed in 7-4. From this fact, it can be said that the safety of the subject device is substantially equivalent 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 seal of the Department of Health & Human Services (HHS). The seal features a stylized image of an eagle with its wings spread, symbolizing protection and care. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle, indicating the department's name and national affiliation.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002
Kuraray Medical, Incorporated C/O Mr. Kiyoyuki Arikawa Kuraray America, Incorporated 600 Lexington Avenue, 26th Floor New York, New York 10022
OCT 2 7 2009
Re: K092281
Trade/Device Name: CLEARFIL MAJESTY Posterior PLT Regulation Number: 21CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Code: EBF Dated: July 24, 2009 Received: August 4, 2009
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.
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 (CDRII'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.
for
Susan Peterson, D.D.S., M.A.
Susan Runner, D.D.S., Acting 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
510(k) Number (if known): KO92281
Device Name: _CLEARFIL MAJESTY Posterior PLT
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)
| Kevin Mulvy for MSR | |
|---|---|
| Division Sign-Off) |
Division of Anesthesiology, General Hospital
Infection Control, Dental Devices
| 510(k) Number: | K092281 |
|---|---|
| ---------------- | --------- |