(70 days)
Re/Stasis™ is a paste containing kaolin clay and aluminum chloride, and is intended to be used for the temporary retraction and hemostasis of the gingival margin during dental procedures. These procedures include dental impressions, restorations, seating of temporary and permanent restorations, placement of rubber dam, and other procedures.
Re/Stasis™ is a paste containing kaolin clay and aluminum chloride
This K111348 document is a 510(k) clearance letter from the FDA for a device named Re/Stasis™. This type of document primarily confirms that the device is "substantially equivalent" to a legally marketed predicate device and grants permission to market it. It does not contain acceptance criteria, details of a clinical study, or performance data.
The sections you've asked for (acceptance criteria, study design, sample sizes, ground truth establishment, expert qualifications, MRMC studies, standalone performance) are typically found in the submission itself, which is not publicly released in this format, or in a Summary of Safety and Effectiveness Data (SSED) if one were available (which is more common for PMA devices).
Therefore, based solely on the provided text, I cannot answer the specific questions about acceptance criteria and study details. The document states that the device is intended for "temporary retraction and hemostasis of the gingival margin during dental procedures." The FDA's determination is based on substantial equivalence, implying that the safety and effectiveness are considered comparable to an existing device without necessarily requiring new clinical trials to demonstrate specific performance metrics for this particular 510(k) submission.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. John Discko Executive Vice President Centrix, Incorporated 770 River Road Shelton, Connecticut 06484 - 5458
Re: K111348
JUL. 2 2 2011
Trade/Device Name: Re / Stasis TM Regulation Number: Unclassified Regulation Name: None Regulatory Class: None Product Code: MVL Dated: April 27, 2011 Received: May 13, 2011
Dear Mr. Discko:
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. Discko
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/C DRHOffices/uc m 1 1 5809.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.
Richard C. Chapman 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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Image /page/2/Picture/1 description: The image shows the Centrix logo. The logo is in a black box with rounded corners, and the word "centrix" is written in white letters inside the box. Below the box, the phrase "Making Dentistry Easier" is written in a smaller font.
Indications for Use
510(k) Number (if known):
Re/Stasis™ Device Name:
Indications For Use:
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Re/Stasis™ is a paste containing kaolin clay and aluminum chloride, and is intended to be used for the temporary retraction and hemostasis of the gingival margin during dental procedures. These procedures include dental impressions, restorations, seating of temporary and permanent restorations, placement of rubber dam, and other procedures.
Prescription Use
(Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
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| Division of Anesthesiology, General Hospital |
| Infection Control, Dental Devices |
| 510(k) Number: | K111348 |
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