(54 days)
Not Found
No
The device description and performance studies focus on the material properties and dispensing system of a composite resin, with no mention of AI or ML capabilities.
No
The device is a restorative composite resin used for dental fillings and corrections, which are not considered therapeutic procedures in the medical sense of treating a disease or disorder. It restores structure rather than providing therapy.
No
The device description indicates it is a restorative composite resin used for direct restorations, correcting tooth position/shape, and repairing fractured crowns/bridges, which are treatment-oriented functions, not diagnostic.
No
The device is a restorative composite resin, which is a physical material used for dental fillings, not a software program.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended uses are for direct restorations, correction of tooth position/shape, and intraoral repairs of 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 shaping teeth.
- Lack of In Vitro Testing: The description focuses on the physical properties of the material and its application directly in the mouth. There is no mention of testing biological samples (blood, urine, tissue, etc.) outside of the body, which is the hallmark of an IVD.
- Performance Studies: The performance studies mentioned are related to compliance with a standard for dental restorative materials (ISO 4049), which focuses on the material's properties and performance in a dental setting, not on diagnostic testing of biological samples.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / 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
Product codes
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.
CLEARFIL MAJESTY Posterior PLT, the applicant device, is substantially the same as CLEARFIL MAJESTY Posterior, the predicate device where the only difference is the container form; the applicant device comes in tips while the predicate device is filled in syringes. The tips used in the applicant device are the same as those used in CLEARFIL AP-X PLT, the predicate device, except for the color. The applicant device is substantially equivalent to the predicate devices.
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)
CLEARFIL MAJESTY Posterior PLT, the applicant device, is verified to comply with the requirements of the applicable FDA recognized consensus standard, ISO 4049: 2000 "Dentistry - Polymer-based filling, restorative and luting materials". As to compare with CLEARFIL MAJESTY Posterior, the predicate device, according to ISO 4049: 2000, both the applicant and the predicate devices comply with ISO 4049: 2000 indicating that the applicant 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
SCHEMATIC SUMMARY
Date: April 27, 2007
510(k) Summary
JUN 2 0 2007
3-1. 510(k) owner (submitter)
-
- Name
-
Address
-
Contact person
-
Contact person in U.S.
KURARAY MEDICAL INC. 1621 Sakazu, Kurashiki, Okayama 710-0801, Japan
Michio Takigawa Quality Assurance Department
CLEARFIL MAJESTY Posterior PLT
(21 CFR section 872.3690. Product code: EBF)
Tooth shade resin material
Restorative composite resin
R001413
Applicant:
510(k) Number:
Classification:
Product Code:
Applicant:
21 CFR Section:
Koji Nishida 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
3-2. Name of Device
-
- Trade / Proprietary name
-
- Classification name
-
Common name
-
Device listing number
3-3. Predicate device
-
CLEARFIL MAJESTY Posterior
-
CLEARFIL AP-X PLT
510(k) Number: K063595 Classification: Tooth shade resin material Product Code: EBF 21 CFR Section:
872.3690 KURARAY MEDICAL INC.
K023002 Tooth shade resin material EBF 872.3690 KURARAY MEDICAL INC.
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.
CLEARFIL MAJESTY Posterior PLT, the applicant device, is substantially the same as CLEARFIL MAJESTY Posterior, the predicate device where the only difference is the container form; the applicant device comes in tips while the predicate device is filled in syringes. The tips used in the applicant device are the same as those used in CLEARFIL AP-X PLT, the predicate device, except for the color. The applicant device is substantially equivalent to the predicate devices.
Quality Assurance Department
1
3-5. Substantial Equivalence Discussion
1) Intended uses
It is intended to be used for the indications listed in the left hand column of the below table that are equivalent to the predicate devices.
Table 3: Indications for Use and predicate devices
| Indications for Use | Predicate devices |
|---|---|
| 1) Direct restorations for anterior and posterior | |
| teeth (Class I - V cavities) | CLEARFIL MAJESTY Posterior, |
| CLEARFIL AP-X PLT | |
| 2) Correction of tooth position and tooth shape | |
| (e.g. diastema closure, dwarfed tooth, etc.) | CLEARFIL MAJESTY Posterior |
| 3) Intraoral repairs of fractured crowns/bridges | CLEARFIL MAJESTY Posterior |
2) Chemical composition / Safety
- All the chemical composition of CLEARFIL MAJESTY Posterior PLT, the applicant device, are exactly the same as those in CLEARFIL MAJESTY Posterior, the predicate device
suggesting the safety of the applicant device is substantially equivalent to the predicat device.
3) Effectiveness / Performance
CLEARFIL MAJESTY Posterior PLT, the applicant device, is verified to comply with the requirements of the applicable FDA recognized consensus standard, ISO 4049: 2000 "Dentistry - Polymer-based filling, restorative and luting materials". As to compare with CLEARFIL MAJESTY Posterior, the predicate device, according to ISO 4049: 2000, both the applicant and the predicate devices comply with ISO 4049: 2000 indicating that the applicant device is as effective as and performs as well as the predicate device.
3-6. Biocompatibility
All the chemical compositions of CLEARFIL MAJESTY Posterior PLT, the applicant device, have been used in the predicate devices as shown in the table of "Section 7: Substantial Equivalence Discussion, Table: 7-2" where all the chemical compositions of the applicant device are listed in the left hand column and the predicate devices containing the composition are listed in the right hand. From that table, it can be said that the safety of the applicant device is substantially equivalent to the predicate devices.
2
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged in a circle around the eagle. The eagle is facing to the right. The image is in black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Kuraray Medical, Incorporated C/O Mr. Koji Nishida Kuraray America, Incorporated 600 Lexington Avenue, 26th Floor New York, New York 10022
JUN 2 0 2007
Re: K071169
Trade/Device Name: CLEARFIL MAJESTY™ Posterior PLT Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Code: EBF Dated: April 27, 2007 Received: May 03, 2007
Dear Mr. Nishida:
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 such 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. Koji Nishida
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Clus
Shia-S. Liu, Ph.D.
Chiu S. Lin, PhD 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
510(k) Number (if known): L07116
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 _ (21 CFR 801 Subpart C)
N/A
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
R. Betz DDS for Dr. Susan Renner
v. General Hos
19(k) Number
2-1