(97 days)
Not Found
No
The description focuses on the chemical composition and curing mechanism of a dental bonding agent, with no mention of AI or ML capabilities.
No
The device is a bonding agent used in dental restorations and related procedures, not for treating diseases or conditions directly.
No
This device is a bonding agent used for dental restorations and treatments. Its intended uses are therapeutic (direct restorations, cavity sealing, treating root surfaces and hypersensitive teeth, repairs, cementation, core build-ups), not diagnostic.
No
The device description clearly states it is a "two component, self-etch, light-cured bonding agent," which is a chemical substance, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description and intended uses clearly indicate that this device is a dental bonding agent used for direct and indirect restorations, cavity sealing, treating exposed root surfaces and hypersensitive teeth, repairing fractured restorations, and cementing various dental prosthetics. These are all procedures performed directly on the patient's teeth and oral structures, not on samples taken from the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information about a patient's health status.
Therefore, this device falls under the category of a dental device used for treatment and restoration, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The subject device is indicated for the following restorative applications:
- [1] Direct restorations using light-cured composite resin
- [2] Cavity sealing as a pretreatment for indirect restorations
- [3] Treatment of exposed root surfaces
- [4] Treatment of hypersensitive teeth
- [5] Intraoral repairs of fractured restorations
- [6] Post cementation using a dual or self-cured composite resin
- [7] Core build-ups using a light-, dual or self-cured core material
- [8] Cementing inlays, onlays, crowns, bridges and veneers using a composite resin cement
Product codes
KLE, EMA, EBF
Device Description
The subject device is a two component, self-etch, light-cured bonding agent, which is intended for universal use for both direct and indirect restorations. The PRIMER allows simultaneous treatment of both dentin and enamel using one liquid. The product is activated by a dual-cure mechanism when the BOND is mixed with CLEARFIL DC Activator. This allows it to be used with dual-cure or self-cure composite filling materials, cements, or core build-up materials.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Dentin, enamel, exposed root surfaces
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)
Certain tests were performed on this device considering its intended uses, in comparison with the predicate device. As the result of the testing, it was confirmed that each tensile bond strength of the subject device was not significantly different or not less than that of the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K012442, K062382, K101423, K111980, K043177
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3200 Resin tooth bonding agent.
(a)
Identification. A resin tooth bonding agent is a device material, such as methylmethacrylate, intended to be painted on the interior of a prepared cavity of a tooth to improve retention of a restoration, such as a filling.(b)
Classification. Class II.
0
[CLEARFIL SE BOND 2. Kuraray Noritake Dental Inc.] Section 3: Summary
Date: June. 12, 2013
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
CLEARFIL SE BOND 2
Dental bonding agent
Agent, Tooth Bonding, Resin
Goro Asanuma 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
(21 CFR section 872.3200. Product code: KLE)
AUG 2 2 2013
3-2. Name of Device
- Trade / Proprietary name
-
- Classification name
- Common name
3-3. Predicate devices
| 1) CLEARFIL SE BOND | 510(k) Number
Classification:
Product Code:
21 CFR Section:
Applicant: | K012442
Agent, Tooth Bonding, Resin
KLE
872.3200
Kuraray Noritake Dental Inc. |
|-----------------------------|-------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------|
| 2) CLERFIL DC BOND | 510(k) Number:
Classification:
Product Code:
21 CFR Section:
Applicant: | K062382
Agent, Tooth Bonding, Resin
KLE
872.3200
Kuraray Noritake Dental Inc. |
| 3) Optibond XTR | 510(k) Number:
Classification:
Product Code:
21 CFR Section:
Applicant: | K101423
Agent, Tooth Bonding, Resin
KLE
872.3200
KERR CORPORATION |
| 4) CLEARFIL TRI-S BOND PLUS | 510(k) Number:
Classification:
Product Code:
21 CFR Section:
Applicant: | K111980
Agent, Tooth Bonding, Resin
KLE
872.3200
Kuraray Noritake Dental Inc. |
| 5) CLEARFIL DC CORE AUTOMIX | 510(k) Number:
Classification:
Product Code:
21 CFR Section:
Applicant: | K043177
Material, Tooth Shade, Resin
EBF
872.3690
Kuraray Noritake Dental Inc. |
1
3-4. Device Description
1
- The subject device is a two component, self-etch, light-cured bonding agent, which is intended for universal use for both direct and indirect restorations. The PRIMER allows simultaneous treatment of both dentin and enamel using one liquid. The product is activated by a dual-cure mechanism when the BOND is mixed with CLEARFIL DC Activator. This allows it to be used with dual-cure or self-cure composite filling materials, cements, or core build-up materials.
This is the new registration application for the subject device and there have not been any prior submissions regarding the subject device.
3-5. Statement of Intended Use
The subject device is indicated for the following restorative applications:
- [1] Direct restorations using light-cured composite resin
- [2] Cavity sealing as a pretreatment for indirect restorations
- [3] Treatment of exposed root surfaces
- [4] Treatment of hypersensitive teeth
- [5] Intraoral repairs of fractured restorations
- [6] Post cementation using a dual or self-cured composite resin
- [7] Core build-ups using a light-, dual or self-cured core material
- [8] Cementing inlays, onlays, crowns, bridges and veneers using a composite resin cement
3-6. Substantial Equivalence Discussion
- l ) Intended uses
The intended uses of the subject device were written up based on those of the predicate devices. Therefore, the intended uses of the subject device are substantially equivalent to those of the predicate devices.
2) Chemical ingredients/ Safety
All ingredients in the subject have been used in the predicate devices.
Regarding the predicate devices, there have not been any reported problems or recalls according to the post market adverse event reporting requirements in the US,
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
Since there have not been any international standards concerning performance of this type of device, certain tests were performed on this device considering its intended uses, in comparison with the predicate device.
As the result of the testing, it was confirmed that each tensile bond strength of the subject device was not significantly different or not less than that of the predicate devices.
Therefore, it was considered that the subject device was as effective as and performs as good as the predicate device.
In conclusion, it can be said that the effectiveness and performance of the subject device are substantially equivalent to those of the predicate device.
3-7. Biocompatibility
The subject device is categorized into the external communicating device (tissue/ bone/ dentin) and permanent contact device.
All the chemical ingredients of the subject device are equivalent to those of the predicate devices. Regarding the predicate devices, there have not been any reported problems or recalls according to the post-market adverse event reporting requirements in the US.
Accordingly. it was considered that the subject device was substantially equivalent in safety to the predicate device.
2
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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem featuring three overlapping, curved shapes that resemble ribbons or stylized wings. The logo is presented in black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 22, 2013
Kuraray Noritake Dental, Inc. C/O Mr. Goro Asanuma General Manger. Dental Materials Division Kurarav America, Incorporated 33 Maiden Lane, 6th Floor New York, NY 10038
Re: K131432
Trade/Device Name: Clearfil SE Bond 2 Regulation Number: 21 CFR 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: II Product Codes: KLE, EMA, EBF Dated: June 12, 2013 Received: June 14, 2013
Dear Mr. Asanuma:
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 - Mr. Asanuma
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 devicerelated 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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/ReportalProblem/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/ResourcesforYou/Industry/default.htm.
Sincerely vours,
Image /page/3/Picture/7 description: The image shows the name "Mary S. Runner -S" in a bold, sans-serif font. The letters are black against a white background, creating a high contrast. The name appears to be a signature or title, with the "S." possibly indicating a middle initial. The overall impression is clean and professional.
Kwame Ulmer M.S. Acting Division 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
510(k) Number (if known): _K131432
Device Name: CLEARFIL SE BOND 2
Indications for Use:
- [1] Direct restorations using light-cured composite resin
- [2] Cavity sealing as a pretreatment for indirect restorations
- [3] Treatment of exposed root surfaces
- [4] Treatment of hypersensitive teeth
- [5] Intraoral repairs of fractured restorations
- [6] Post cementation using a dual- or self-cured composite resin
- [7] Core build-ups using a light-, dual- or self-cured core material
- [8] Cementing inlays, onlays, crowns, bridges and veneers using a composite resin cement
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)
Andrew I-Steen-S
2013.08.20 14:10:21 -04'00'
(Division Sign-Off) (Division Sign-Off)
Division of Anestheslology, General Hospital
Division of Anestheslology, General Devices Division of Antost. Dental Devices
K131432 510(k) Number;