(78 days)
Racegel™ is a gel containing aluminium chloride which is intended for sulcus retraction prior to impression taking; control of bleeding and gingival oozing, particularly in restorative dentistry; and, if using a gingival retraction cord, the gel facilitates the insertion of the cord into the sulcus.
Racegel™ is a gel containing aluminium chloride.
The provided document is an FDA 510(k) clearance letter for a dental product called Racegel™. This document does not describe acceptance criteria or a study proving that a device meets acceptance criteria. Instead, it is a regulatory document stating that the product is substantially equivalent to legally marketed predicate devices.
Therefore, I cannot provide the requested information based on the input document. The document primarily focuses on regulatory approval and indications for use, not on performance studies or acceptance criteria comparisons.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
SEPTODONT C/O Mr. Wayne H. Matelski Official Correspondent Arent Fox LLP 1050 Connecticut Avenue, NW Suite 400 Washington, DC 20036-5339
FEB 1 7 2010
Re: K093711
Trade/Device Name: RacegeITM Regulation Number: Unclassified Regulation Name: None Regulatory Class: None Product Code: MVL Dated: November 30, 2009 Received: December 1, 2009
Dear Mr. Matelski:
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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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 liederal 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/ucml 15809.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.
Susan Kunne
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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II. Indications for Use Statement
Indications for Use
510(K) Number: (if known)
Device Name: RacegeI™
Indications for Use:
Racegel™ is a gel containing aluminium chloride which is intended for sulcus retraction prior to impression taking; control of bleeding and gingival oozing, particularly in restorative dentistry; and, if using a gingival retraction cord, the gel facilitates the insertion of the cord into the sulcus.
Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
K.Schatz DMS for Dr. K. Muhle
Division Sign-Off)/ ·············································································································································································· nection Control, Dental Devices
510(k) Number: K093711
S0004
N/A