(44 days)
Not Found
No
The device is a composite resin material for dental restorations and the description focuses on its physical properties and dispensing system, with no mention of AI or ML.
No
The device is a restorative composite resin used for dental fillings, veneers, and repairs. While it addresses dental conditions, it does not fit the typical definition of a therapeutic device designed for treatment, therapy, or rehabilitation of diseases or medical conditions. It is a material used for restoration.
No
The device is a restorative composite resin used for direct restorations, veneers, and repairs, not for diagnosing medical conditions.
No
The device description clearly states it is a "light-cure, radiopaque restorative composite resin" and comes in "tips," indicating it is a physical material and dispensing system, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as a restorative material for direct applications on teeth (fillings, veneers, shape correction, repairs). This is a therapeutic and restorative function performed directly on the patient's body.
- Device Description: The description confirms it's a "light-cure, radiopaque restorative composite resin." This is a material used to physically restore 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) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used outside the body to analyze samples and provide diagnostic information. This device is used inside the body to repair and restore tooth structure.
N/A
Intended Use / Indications for Use
CLEARFIL MAJESTY Esthetic PLT is indicated for the following restorative applications:
-
- Direct restorations for anterior and posterior teeth (Class I V cavities)
-
- Direct veneers
-
- 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 Esthetic 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 Esthetic PLT, with its special dispensing system, can be quickly and conveniently placed directly into the cavity.
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)
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". Both the applicant device and the predicate devices comply with the standard.
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: February 2, 2007
510(k) Summary
3-1. 510(k) owner (submitter)
MAR 2 1 2007
| 1) Name | KURARAY MEDICAL INC. |
|---|---|
| 2) Address | 1621 Sakazu, Kurashiki, Okayama 710-0801, Japan |
| 3) Contact person | Michio Takigawa |
| Quality Assurance Department | |
| 4) Contact person in U.S. | 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 | |
| 1) Trade / Proprietary name | CLEARFIL MAJESTY Esthetic PLT |
| 2) Classification name | Tooth shade resin material |
| (21 CFR section 872.3690. Product code: EBF) | |
| 3) Common name | Restorative composite resin |
| 4) Device listing number | R001413 |
| 3-3. Predicate device | |
| 1) CLEARFIL MAJESTY Esthetic | 510(k) Number: K061860 |
| Classification: Tooth shade resin material | |
| (21 CFR section 872.3690. Product code: EBF) | |
| Applicant: KURARAY MEDICAL INC. | |
| 2) CLEARFIL AP-X PLT | 510(k) Number: K023002 |
| Classification: Tooth shade resin material | |
| (21 CFR section 872.3690. Product code: EBF) | |
| Applicant: KURARAY MEDICAL INC. |
3-4. Description of device
CLEARFIL MAJESTY Esthetic 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 Esthetic PLT, with its special dispensing system, can be quickly and conveniently placed directly into the cavity.
CLEARFIL MAJESTY Esthetic PLT, the applicant device, is substantially the same as CLEARFIL MAJESTY Esthetic, 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. Therefore, the applicant device is substantially equivalent to the predicate devices.
1
3-5. Intended uses
CLEARFIL MAJESTY Esthetic PLT is indicated for the following uses:
- Direct restorations for anterior and posterior teeth (Class I V cavities) י
- . Direct veneers
- -Correction of tooth position and tooth shape (e.g. diastema closure, dwarfed tooth, etc.)
- . Intraoral repairs of fractured crowns/bridges
The intended uses of CLEARFIL MAJESTY Esthetic PLT are exactly the same as those of CLEARFIL MAJESTY Esthetic.
3-6. Technological characteristics of device
1) Safety
The chemical ingredients and the composition of CLEARFIL MAJESTY Esthetic PLT, the applicant device, are exactly the same as those in CLEARFIL MAJESTY Esthetic, the predicate device suggesting the safety of the applicant device is substantially equivalent to the predicate device.
2) Effectiveness / Performance
CLEARFIL MAJESTY Esthetic 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 Esthetic, the predicate device, according to ISO 4049: 2000, both the applications the predicate devices comply with the standard indicating the applicant device is as effective and performs as well as the predicate device.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird-like figure with three human profiles incorporated into its design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the emblem.
ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Kurarav Medical, Incorporated C/O Mr. Koji Nishida Kuraray America, Incorporated 600 Lexington Avenue, 26th Floor New York, New York 10022
MAR 2 1 2007
Re: K070325
Trade/Device Name: CLEARFIL MAJESTY™ Esthetic PLT Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Code: EBF Dated: February 02, 2007 Received: February 07, 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 (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.
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,
Clubs
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
L070325
510(k) Number (if known):
Device Name: CLEARFIL MAJESTY Esthetic PLT
Indications for Use:
CLEARFIL MAJESTY Esthetic PLT is indicated for the following restorative applications:
-
- Direct restorations for anterior and posterior teeth (Class I V cavities)
-
- Direct veneers
-
- 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)
Reberzons for Dr. Susan Runner
2-1