(148 days)
- [1] Surface treatment of prosthetic restorations made of ceramic, hybrid ceramics, composite resin or metal
- [2] Intraoral repairs of fractured restorations made of ceramics, hybrid ceramics, composite resin or metal
Not Found
The provided text is a US FDA 510(k) clearance letter for the device "CLEARFIL CERAMIC PRIMER PLUS". This document confirms that the device has been found substantially equivalent to predicate devices. However, this type of document does not contain the information requested in your bullet points regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment.
The FDA 510(k) summary (which is a separate document typically published alongside the clearance letter) or the submission itself would contain details about the performance data. Without access to those documents, I cannot provide the requested information.
The clearance letter focuses on:
- Confirming substantial equivalence.
- Listing the device name, regulation number, and product code.
- Outlining regulatory compliance responsibilities for the manufacturer.
- Specifying the "Indications for Use" for the device.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and reported device performance.
- Sample sizes used for the test set and data provenance.
- Number and qualifications of experts for ground truth.
- Adjudication method.
- MRMC comparative effectiveness study details.
- Standalone performance details.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 13, 2015
Kuraray Noritake Dental Inc. Michio Takigawa Manager, Quality Assurance Department Ote Center Bldg 7F 1-1-3, Otemachi Chiyoda, Tokyo 100-0004 JAPAN
Re: K150703
Trade/Device Name: CLEARFIL CERAMIC PRIMER PLUS Regulation Number: 21 CFR 872.3200 Regulation Name: Agent tooth Bonding, Resin Regulatory Class: II Product Code: KLE Dated: May 18, 2015 Received: May 19, 2015
Dear: Mr. Takigawa
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. 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
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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 contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education 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 yours.
Erin | Keith -S
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
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Indications for Use
510(k) Number (if known):
Device Name: CLEARFIL CERAMIC PRIMER PLUS
Indications for Use:
- [1] Surface treatment of prosthetic restorations made of ceramic, hybrid ceramics, composite resin or metal
- [2] Intraoral repairs of fractured restorations made of ceramics, hybrid ceramics, composite resin or metal
Prescription Use ___ ∨ (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (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)
§ 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.