(60 days)
CLEARFIL MAJESTY Flow is indicated for the following restorative applications:
- Direct restorations for anterior and posterior teeth (Class I III, V cavities, cervical caries, root erosion)
- Cavity base / liner
- Intraoral repairs of fractured crowns / bridges / composite resin
CLEARFIL MAJESTY Flow is a flowable, radiopaque restorative composite resin which provides true to life color matching, high polish ability and excellent physical properties, making ideal for both anterior and posterior restorations. CLEARFIL MAJESTY Flow can be used alone or together with CLEARFIL AP-X and CLEARFIL MAJESTY Esthetic. It is classified into tooth shade resin materia" (21 CFR section 872.3690, Product code: EBF ) according to 21 CFR § 872 since it is composed of materials such as methacrylate monomers.
This 510(k) summary describes a dental restorative material, not a software or AI-enabled device, and therefore the requested information regarding AI-specific evaluations (such as sample sizes for test and training sets, expert adjudication methods, MRMC studies, or standalone performance) is not applicable or extractable from the provided text.
The acceptance criteria and study information provided in the document pertain to the physical and chemical properties of a dental resin material.
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Criterion (from ISO 4049: 2000) | Acceptance Criteria | Reported Device Performance (CLEARFIL MAJESTY Flow) |
|---|---|---|
| Safety | Not explicitly stated as numerical criteria in this document, but implied by use of known ingredients. | All chemical ingredients have been used in predicate devices, indicating substantial equivalence in safety. |
| Effectiveness / Performance (General) | Compliance with ISO 4049: 2000 "Dentistry - Polymer-based filling, restorative and luting materials" | The applicant device (CLEARFIL MAJESTY Flow) complies with the requirements of ISO 4049: 2000. |
Study that Proves the Device Meets Acceptance Criteria:
The study proving the device meets the acceptance criteria is an evaluation against the ISO 4049: 2000 "Dentistry - Polymer-based filling, restorative and luting materials" consensus standard.
2. Sample size used for the test set and the data provenance:
Not applicable as this is a material science study adhering to an ISO standard, not a data-driven AI study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
Not applicable. The ground truth is established by the ISO standard's defined tests and methodologies for material properties, not by expert interpretation of data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. Testing is based on standardized physical and chemical measurements according to ISO 4049:2000.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
No, an MRMC study was not done as this is a material science study, not an AI-assisted diagnostic or interpretive device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The "ground truth" for this device's performance is compliance with the specified physical and chemical property requirements outlined in the ISO 4049: 2000 standard for dental polymer-based restorative materials.
8. The sample size for the training set:
Not applicable as this is a material science study, not a machine learning study.
9. How the ground truth for the training set was established:
Not applicable as this is a material science study. The "ground truth" for material properties is inherent in the internationally recognized ISO standard and its associated test methods.
{0}------------------------------------------------
Jouluravay
[CLEARFIL MAIESTY Flow, KURARAY MEDICAL INC.] Section 3: Summary
FEB - 2 2007
Date: December 1, 2006
510(k) Summary
3-1. 510(k) owner (submitter)
| 1) Name | KURARAY MEDICAL INC. | |
|---|---|---|
| 2) Address | 1621 Sakazu, Kurashiki, Okayama 710-0801, Japan | |
| 3) Contact person | Michio TakigawaQuality Assurance Department | |
| 4) Contact person in U.S. | Koji NishidaKURARAY AMERICA INC.600 Lexington Avenue, 26th FloorNew York. NY 10022Tel: (212) 986-2230 (Ext. 115) or (800)-879-1676Fax: (212) 867-3543 | |
| 3-2. Name of Device | ||
| 1) Trade / Proprietary name | CLEARFIL MAJESTY Flow | |
| 2) Classification name | Tooth shade resin material(21 CFR section 872.3690. Product code: EBF) | |
| 3) Common name | Flowable restorative composite resin | |
| 4) Device listing number | R001413 | |
| 3-3. Predicate device | ||
| 1) TETRIC FLOW | 510(k) Number:Product Code:Applicant: | K993783EBF (21 CFR Section: 872.3690)IVOCLAR NORTH AMERICA, INC |
| 2) CLEARFIL AP-X | 510(k) Number:Product Code:Applicant: | K012740EBF (21 CFR Section: 872.3690)KURARAY MEDICAL INC. |
| 3) EPRICORD | 510(k) Number:Product Code:Applicant: | K033267EBF (21 CFR Section: 872.3690)KURARAY MEDICAL INC. |
| 4) CLEARFIL SE BOND | 510(k) Number:Product Code:Applicant: | K012442KLE (21 CFR Section: 872.3200)KURARAY MEDICAL INC. |
3-4. Description of device
CLEARFIL MAJESTY Flow is a flowable, radiopaque restorative composite resin which provides true to life color matching, high polish ability and excellent physical properties, making ideal for both anterior and posterior restorations. CLEARFIL MAJESTY Flow can be used alone or together with CLEARFIL AP-X and CLEARFIL MAJESTY Esthetic.
It is classified into tooth shade resin materia" (21 CFR section 872.3690, Product code: EBF ) according to 21 CFR § 872 since it is composed of materials such as methacrylate monomers.
{1}------------------------------------------------
According to the applicable FDA recognized consent us standard, ISO 4049: 2000 "Dentistry -Polymer-based filling, restorative and luting materials'', this device is classified into the following:
- Type 1: polymer-based filling and restorative materials; -
- Class 2: materials whose setting is effected by light; ・
- Group 1: materials whose use requires the «nergy to be applied intra-orally. -
3-5. Intended uses
CLEARFIL MAJESTY Flow is indicated for the following restorative applications:
- CEEANN ID MI WEST I 101 is marcates erior teeth. (Class I -- III, V cavities, cervical caries, root erosion)
- Cavity base / liner
- Intraoral repairs of fractured crowns / bridges / composite resin
The intended uses of CLEARFIL MAJESTY Flow are substantially equivalent to those included in the indications for use of TETRIC FLOW, the predicate device.
3-6. Technological characteristics of device
1) Safety
All the chemical ingredients of CLEARFIL MA.JESTY Flow, the applicant device, have been used in the predicate devices indicating that the safety of the applicant device is substantially equivalent to the predicate devices.
2) Effectiveness / Performance
CLEARFIL MAJESTY Flow, the applicant device, is verified to comply with the requirements of the applicable FDA recognized consensus staudard, ISO 4049: 2000 "Dentistry - Polymer-based filling, restorative and luting materials". As to compare with the predicate devices according to ISO 4049: 2000, both the applicant and the predicate device comply with ISO 4049: 2000 indicating that the applicant device is as effective as and nerforms as well as the predicate devices.
{2}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/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 tail feathers, representing the three levels of government: federal, state, and local. The eagle is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the left side of the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Koji Nishida General Manager Kuraray America, Incorporated 600 Lexington Avenue, 26th Floor New York, New York 10022
FEB - 2 2007
Re: K063593
Trade/Device Name: CLEARFIL MAJESTY Flow Regulation Number: 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Code: EBF Dated: December 1, 2006 Received: December 11, 2006
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. 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" (21CFR Part 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Clus
Chiu Lin, Ph.D. 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): _
Device Name: CLEARFIL MAJESTY Flow
Indications for Use:
CLEARFIL MAJESTY Flow is indicated for the following restorative applications:
- Direct restorations for anterior and posterior teeth (Class I III, V cavities, cervical caries, root erosion)
- Cavity base / liner
- Intraoral repairs of fractured crowns / bridges / composite resin
Prescription Use _________X AND/COR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use _ N/A (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW "I'HIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
неродника монение машина. «Сетромандарам» мотов» - темалова с Мили Моски и мости изментирации и п
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susa Runge
12 2018-52. 8 11 24 ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
2063593
§ 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.