(28 days)
Vita VMK Master® is indicated for use as part of a dental restoration in the form of a ceramic veneering material (full or partial) of a metal substructure.
Not Found
I apologize, but the provided text from the FDA 510(k) K093446 for "Vita VMK Master®" does not contain information about acceptance criteria, device performance metrics, or details of a study that would prove the device meets such criteria.
The document is a clearance letter stating that the device is substantially equivalent to legally marketed predicate devices. It covers regulatory aspects, such as compliance with FDA regulations, registration, labeling, and adverse event reporting.
The "Indications for Use" section simply describes the intended purpose of the device as a ceramic veneering material for a metal substructure in dental restorations, to be used by a dental professional.
Therefore, I cannot provide the requested information based on the given input.
{0}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features the department's name encircling a stylized image of an eagle. The eagle is depicted with its wings spread, symbolizing protection and service. The seal is used to represent the HHS and its mission to enhance the health and well-being of Americans.
DEC - 3 2009
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
Vita Zahnfabrik H. Rauter GmbH & Company KG C/O Ms. Elizabeth Wolfsen Regulatory Affairs Specialist Vident 3150 East Birch Street Brea, California 92821
Re: K093446
Trade/Device Name: Vita VMK Master® Regulation Number: 21CFR 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: II Product Code: EIH Dated: November 4, 2009 Received: November 6, 2009
Dear Ms. Wolfsen:
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.
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.
{1}------------------------------------------------
Page 2- Ms. Wolfsen
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/ReportalProblem/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.
for
Susan Runner, D.D.S., M.A. Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Indications for Use
510(k) Number (if known):
Device Name: Vita VMK Master® Indications for Use:
Vita VMK Master® is indicated for use as part of a dental restoration in the form of a ceramic veneering material (full or partial) of a metal substructure.
For use by or on the order of a dental professional such as DDS or DMD. Not for use by the general public or OTC.
Prescription Use × (21 CFR Part 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR Part 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
R.Betz DOS for Dr. Kevin Muhling
vision of Dental, Infection Control and General Hospital Devices
510(k) Number
Prescription Use (Par. 21 CFR 801.109 OR
Over-The-Counter Use
Page 1 of 1
§ 872.6660 Porcelain powder for clinical use.
(a)
Identification. Porcelain powder for clinical use is a device consisting of a mixture of kaolin, felspar, quartz, or other substances intended for use in the production of artificial teeth in fixed or removable dentures, of jacket crowns, facings, and veneers. The device is used in prosthetic dentistry by heating the powder mixture to a high temperature in an oven to produce a hard prosthesis with a glass-like finish.(b)
Classification. Class II.