(219 days)
LANG DENTAL TOOTH SHADE TEMPORARY CROWN AND BRIDGE ACRYLIC RESIN is intended for the fabrication of temporary crowns and bridges.
Not Found
This document is a 510(k) clearance letter from the FDA for a dental device. It does not contain information about acceptance criteria or study data for device performance. It confirms that the device is substantially equivalent to a predicate device and can be marketed.
Therefore, I cannot provide the requested information based on the provided text. The document does not describe:
- Acceptance criteria and reported device performance.
- Sample sizes, data provenance, or details of expert involvement for ground truth establishment.
- Adjudication methods.
- MRMC comparative effectiveness studies or standalone algorithm performance.
- The type of ground truth used or details about training sets.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with its wings spread, symbolizing protection and care. The eagle is positioned within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" is arranged around the circle's perimeter.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN - 5 2009
Chah M. Shen, Ph.D. Director of Research and Development Lang Dental Manufacturing Company, Incorporated 175 Messner Drive Wheeling, Illinois 60090-0969
Re: K083195 .
Trade/Device Name: Lang Dental Tooth Shade Temporary Crown and Bridge Acrylic Resin Regulation Number: 21 CFR 872.3770 Regulation Name: Temporary Crown and Bridge Resin Regulatory Class: II Product Code: EBG Dated: May 26, 2009 Received: June 2, 2009
Dear Dr. Shen:
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 - Dr. Shen
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/cdrh/comp/ 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/cdrh/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Susan Russo
Susan Runner, D.D.S., MA Acting Division 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 OF DEVICE CLAIMED EQUIVALENCY LANG DENTAL JET TOOTH SHADE TEMPORARY CROWN AND BRIDGE ACRYLIC RESIN
510(k) Number (if known):
Device Name: Lang Dental Tooth Shade Temporary Crown and Bridge Acrylic Resin
Indications for Use:
LANG DENTAL TOOTH SHADE TEMPORARY CROWN AND BRIDGE ACRYLIC RESIN is intended for the fabrication of temporary crowns and bridges.
Prescription Use X (21 CFR part 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Kein Mulley for MSE
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
Page 1 of
510(k) Number: K083195
§ 872.3770 Temporary crown and bridge resin.
(a)
Identification. A temporary crown and bridge resin is a device composed of a material, such as polymethylmethacrylate, intended to make a temporary prosthesis, such as a crown or bridge, for use until a permanent restoration is fabricated.(b)
Classification. Class II.