(94 days)
[1] Direct restorations using light cured composite resin
[2] Cavity sealing as a pretreatment for indirect restorations
[3] Treatment of exposed root surfaces
[4] Intraoral repairs of fractured restorations made of porcelain, ceramic or composite resin
[5] Surface treatment of prosthetic restorations made of porcelain, ceramic or composite resin
[6] Surface treatment of dental posts
[7] Post cementation and core build ups using dual cured composite resin CLEARFIL DC CORE PLUS
[8] Core build ups using light cured composite resin
The subject device is a single-component, light-cured bonding agent that allows simultaneous treatment of both dentin and enamel.
The provided text describes the regulatory submission for a dental bonding agent, CLEARFIL TRI-S BOND PLUS, and references studies conducted to demonstrate its substantial equivalence to predicate devices. However, the document does not contain explicit "acceptance criteria" in a quantitative tabular format or detailed "studies that prove the device meets acceptance criteria" with the specific information requested in your prompt (e.g., sample sizes for test/training sets, data provenance, expert ground truth details, MRMC studies, standalone performance details).
Instead, the submission focuses on demonstrating substantial equivalence based on
- Intended uses
- Chemical ingredients/safety (biocompatibility)
- Technological characteristics/effectiveness and performance.
The document indicates that for effectiveness and performance, "certain tests were performed on this device, in comparison with the predicate device and it was confirmed that this device was substantially equivalent to the predicate device in terms of the effectiveness and performance." Specifically, the following tests are mentioned:
- Tensile bond strength test
- Fluoride releasing property
The results of these tests "exhibited almost the same results for the subject device indicating that the subject device was as effective as and performs as good as or better than the predicate device."
Without the full study reports, which are not included in this summary, the detailed information requested cannot be fully extracted. However, based on the provided text, here's what can be inferred:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Inferred from "Substantially Equivalent") | Reported Device Performance |
|---|---|
| Tensile Bond Strength: Comparable to or better than predicate devices (CLEARFIL TRI-S BOND, CLEARFIL DC BOND). | Exhibited "almost the same results" as the predicate device for tensile bond strength, indicating it was "as effective as and performs as good as or better than" the predicate device. |
| Fluoride Releasing Property: Comparable to or better than predicate devices (CLEARFIL TRI-S BOND, CLEARFIL DC BOND). | Exhibited "almost the same results" as the predicate device for fluoride releasing property, indicating it was "as effective as and performs as good as or better than" the predicate device. |
| Biocompatibility: Meet ISO 10993 series and ISO 7405 standards. | 2 new ingredients evaluated with ISO 10993 series and ISO 7405 and "it was confirmed that these substances were biocompatible." All other ingredients previously used in predicate devices with no reported problems. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified in the provided summary.
- Data Provenance: Not specified in the provided summary.
- The submitter is Kuraray Medical Inc., located in Japan, suggesting the studies likely originated from there, but this is an inference, not stated directly about the data itself.
- The studies were part of a 510(k) submission, typically involving prospective testing for performance evaluations.
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 as the tests described (tensile bond strength, fluoride release) are objective laboratory measurements, not subjective evaluations requiring expert ground truth in the way medical imaging interpretation might.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable for objective laboratory measurements like tensile bond strength or fluoride release.
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, this type of study is not mentioned. The device is a dental bonding agent, not an AI-powered diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. The device is a physical product (dental bonding agent), not an algorithm. Its performance is inherent to the material properties.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- For Tensile Bond Strength and Fluoride Releasing Property: The "ground truth" would be the direct measurement of these physical/chemical properties using established laboratory testing protocols, likely aligned with ISO or ASTM standards, and validated against the performance of predicate devices.
- For Biocompatibility: The ground truth was established by evaluation against ISO 10993 series and ISO 7405 standards.
8. The sample size for the training set
- Not applicable. The description refers to a medical device (dental bonding agent), not an AI algorithm that requires a training set. Development of such a product involves formulation and testing, but not in the "training set" sense for AI.
9. How the ground truth for the training set was established
- Not applicable as there is no "training set" in the context of this device.
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Image /page/0/Picture/0 description: The image shows the text "K111980" in a handwritten style. The characters are bold and slightly slanted to the right. The "K" is larger than the other characters, and the "1"s are close together. The "980" is also close together, and the "0" is slightly smaller than the "9" and "8".
[CLEARFIL TRI-S BOND PLUS, KURARAY MEDICAL INC.] Section 3: Summary
July 6, 2011 Date:
OCT 1 4 2011
ﺎ ﺳﯿﺴﻪ ﻋ
510(k) Summary
3-1. 510(k) owner (submitter)
-
Name
-
Address
-
Contact person
-
Contact person in US
KURARAY MEDICAL INC.
1621 Sakazu, Kurashiki, Okayama 710-0801, Japan
Michio Takigawa Quality Assurance Department
Kiyoyuki Arikawa 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 CLEARFIL TRI-S BOND PLUS 2) Classification name
Dental bonding agent
510(k) Number:
21 CFR Section:
Product Code:
Product Code:
21 CFR Section:
Applicant:
Applicant:
Resin Tooth Bonding Agent (21 CFR section 872.3690. Product code: KLE)
KLE
- Common name
3-3. Predicate device
-
CLEARFIL TRI-S BOND
-
CLEARFIL DC BOND
-
PANAVIA F 2.0
-
CLEARFIL MAJESTY Flow
872.3690 KURARAY MEDICAL INC. K062382
510(k) Number: KLE 872.3200 KURARAY MEDICAL INC.
510(k) Number: K032455 Product Code: EMA 21 CFR Section: 872.3275 Applicant: KURARAY MEDICAL INC.
510(k) Number: K063593 Product Code: EBF 21 CFR Section: 872.3690 Applicant: KURARAY MEDICAL INC.
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3-4. Device Description
The subject device is a single-component, light-cured bonding agent that allows simultaneous treatment of both dentin and enamel.
3-5. Substantial Equivalence Discussion
- l) Intended uses
The intended uses of the subject device were written up based on those of CLEARFIL TRI-S BOND and CLEARFIL DC BOND, the predicate devices.
Therefore, the intended uses of the subject device are substantially equivalent to those of the predicate devices.
-
- Chemical ingredients / Safety
Except for 2 new chemical ingredients, all ingredients in the subject device 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.
- Chemical ingredients / Safety
And 2 new ingredients have been evaluated referring to ISO 10993 series and ISO 7405. As the result, it was confirmed that these substances were biocompatible. 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, in comparison with the predicate device and it was confirmed that this device was substantially equivalent to the predicate device in terms of the effectiveness and performance.
Tensile bond strength test and Fluoride releasing property were performed to validate the substantial equivalence of the subject device with the predicate device in terms of effectiveness and performance for the intended uses. The test has exhibited almost the same results for the subject device indicating that the subject device was as effective as and performs as good as or better than the predicate device.
3-6. Biocompatibility
Except for 2 new chemical ingredients, all ingredients in the subject device 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.
And 2 new ingredients have been evaluated referring to ISO 10993 series and ISO 7405. As the result, it was confirmed that these substances were biocompatible.
In conclusion, it was concluded that the biocompatibility of the subject device could be assured.
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes representing the three branches of government. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the left side of the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -W066-G609 Silver Spring, MD 20993-0002
OCT 1 4 2011
Kurarav Medical, Incorporated C/O Mr. Kiyoyuki Arikawa General Manger Kurarav America, Incorporated 600 Lexington Avenue, 26th Floor New York, NY 10022
Re: K111980
Trade/Device Name: Clearfil Tri-S Bond Plus Regulation Number: 21 CFR 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: II Product Code: KLE Dated: July 6, 2011 Received: July 12, 2011
Dear Mr. Arikawa:
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.
.
.
.
.
.
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Page 2 - Mr. Arikawa
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 device-related 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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,
Nh for
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
211980 510(k) Number (if known):
Device Name: CLEARFIL TRI-S BOND PLUS
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] Intraoral repairs of fractured restorations made of porcelain, ceramic or composite resin
- [5] Surface treatment of prosthetic restorations made of porcelain, ceramic or composite resin
- [6] Surface treatment of dental posts
- [7] Post cementation and core build ups using dual cured composite resin CLEARFIL DC CORE PLUS
... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
[8] Core build ups using light cured composite resin": " :
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 apr AND DA
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number:
2-1
§ 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.