(87 days)
Not Found
No
The device description and intended use relate to a dental bonding agent and its chemical properties, with no mention of AI/ML or related concepts.
No
The device is a bonding agent used for dental restorations and cementation. While it facilitates the repair and sealing of teeth, its primary function is not to treat or cure a disease or condition, but rather to aid in restorative procedures.
No
The device is a bonding agent used for restorative dental procedures and cementation. It does not mention any function related to identifying, analyzing, or diagnosing medical conditions.
No
The device description clearly states it is a "single-component, light-cured bonding agent," 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 uses listed are all related to dental procedures performed directly on the patient's teeth (restorations, sealing, treating surfaces, cementation). IVDs are used to examine specimens (like blood, urine, tissue) taken from the body to provide information about a person's health.
- Device Description: The description clearly states it's a "single-component, light-cured bonding agent" used for "simultaneous treatment of both dentin and enamel." This is a material applied to the patient, not a test performed on a sample from the patient.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information about a patient's health status.
The device is a dental material used for bonding and restoration procedures, which falls under the category of medical devices, but not specifically In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The subject device is indicated for the following uses:
[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 and core build-ups
[7] Cementation of inlays, onlays, crowns, bridges and veneers
Product codes (comma separated list FDA assigned to the subject device)
KLE, LBH
Device Description
The subject device is a single-component, light-cured bonding agent that allows simultaneous treatment of both dentin and enamel. Depending on the adhesive is used as self-etching or with phosphoric acid for selective enamel etching or total-etching procedures. This product is intended to be used for both direct and indirect restorations.
"CLEARFIL DC Activator" activates the dual-curing mechanism of this product; however, the addition of "CLEARFIL DC Activator" to the adhesive is not required when using with "CLEARFIL DC CORE PLUS" or "PANAVIA SA CEMENT".
This is the new registration application for the subject device and there have not been any prior submissions regarding the subject device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Dentin, enamel, root surfaces, 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)
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 testings, it was confirmed that the performance 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.
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
§ 872.3200 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
K132450 [CLEARFIL Universal Bond, Kuraray Noritake Dental Inc.] Section 3: Summary
September 3, 2013 Date:
510(k) Summary
3-1. 510(k) owner (submitter)
l ) Name
- Address
NOV 0 1 2013
-
Contact person
-
Contact person in US
Kuraray Noritake Dental Inc.
1621 Sakazu, Kurashiki, Okayama 710-0801, Japan
Michio Takigawa Quality Assurance Department
CLEARFIL Universal Bond
Agent, Tooth Bonding, Resin
Dental bonding agent
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)
3-2. Name of Device
- Trade / Proprietary name
-
- Classification name
- Common name
3-3. Predicate devices
| a a s a le while de contract and the count | ||
|---|---|---|
| 1) 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. | ||
| 2) Scotchbond Universal Adhesive | 510(k) Number: | |
| Classification: | ||
| Product Code: | ||
| 21 CFR Section: | ||
| Applicant: | Unknown | |
| Agent, Tooth Bonding, Resin | ||
| KLE | ||
| 872.3200 | ||
| 3M ESPE | ||
| 3) CLEARFIL TRI-S BOND | 510(k) Number: | |
| Classification: | ||
| Product Code: | ||
| 21 CFR Section: | ||
| Applicant: | K042913 | |
| Agent, Tooth Bonding, Resin | ||
| KLE | ||
| 872.3200 | ||
| Kuraray Noritake Dental Inc. | ||
| 4) CLEARFIL CERAMIC PRIMER | 510(k) Number: | |
| Classification: | ||
| Product Code: | ||
| 21 CFR Section: | ||
| Applicant: | K061906 | |
| Material, Tooth shade, Resin | ||
| EBF | ||
| 872.3690 | ||
| Kuraray Noritake Dental Inc. | ||
1
3-4. Device Description
The subject device is a single-component, light-cured bonding agent that allows simultaneous treatment of both dentin and enamel. Depending on the adhesive is used as self-etching or with phosphoric acid for selective enamel etching or total-etching procedures. This product is intended to be used for both direct and indirect restorations.
"CLEARFIL DC Activator" activates the dual-curing mechanism of this product; however, the addition of "CLEARFIL DC Activator" to the adhesive is not required when using with "CLEARFIL DC CORE PLUS" or "PANAVIA SA CEMENT"
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 uses:
[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 and core build-ups
[7] Cementation of inlays, onlays, crowns, bridges and veneers
3-6. Substantial Equivalence Discussion
- l ) Intended uses
The intended uses of the subject device were written up based on those of CLEARFIL TRI-S BOND PLUS and Scotchbond Universal Adhesive.
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.
Accordingly, it was concluded that the safety of the subject device was substantially equivalent to that of the predicate devices.
- 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 testings, it was confirmed that the performance 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.
Accordingly, it was concluded that the effectiveness and performance of the subject device were substantially equivalent to those of the predicate devices.
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 concluded that the subject device was substantially equivalent in safety to the predicate devices.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo features a stylized eagle with three stripes representing the three branches of government. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 1, 2013
Kuraray Noritake Dental, Inc. C/O Mr. Goro Asanuma General Manger, Dental Materials Division Kuraray America, Incorporated 33 Maiden Lane, 6th Floor New York, NY 10038
Re: K132450
Trade/Device Name: Clearfil Universal Bond Regulation Number: 21 CFR 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: II Product Codes: KLE, LBH Dated: September 3, 2013 Received: September 6, 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 (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.
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/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,
Mary Si Runner -S
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): K132450
Device Name: CLEARFIL Universal Bond
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 and core build-ups
- [7] Cementation of inlays, onlays, crowns, bridges and veneers
| Prescription Use | V |
|---|---|
| (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)
Lauren
M. Giles
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9.2342.19200300.100.1.1=2000646
for AIS