(43 days)
Anterior restorations (Class III, IV)
Tooth Neck restorations (Class V, e.g. cervical caries, root erosion, wedge-shaped defects)
Restorations in the posterior region (Class I and II)
Direct Veneers
Corrections of tooth positions and tooth shape (e.g. diastema closure, closure of interdental "black triangles," lengthening of the incisal edge
Not Found
The provided text is a 510(k) clearance letter from the FDA for the device "EMPRESS® DIRECT". This document primarily focuses on the regulatory clearance process, stating that the device is substantially equivalent to a predicate device.
Crucially, this document does not contain any information about acceptance criteria, the study design, or performance metrics. It's a regulatory approval letter, not a scientific study report.
Therefore, I cannot provide the requested information. The text does not contain:
- A table of acceptance criteria and reported device performance.
- Sample sizes or data provenance for a test set.
- Number or qualifications of experts for ground truth establishment.
- Adjudication method for a test set.
- Information about a multi-reader multi-case (MRMC) comparative effectiveness study.
- Information about a standalone performance study.
- The type of ground truth used.
- The sample size for a training set.
- How the ground truth for the training set was established.
This document indicates the device's intended uses (Indications For Use) and its product code (EBF, which is associated with tooth restorative material, resin, for permanent use). To find the kind of information requested, one would typically need to consult a clinical study report submitted as part of the 510(k) application, which is not included here.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features an eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" are arranged in a circular pattern around the eagle. The eagle is black, and the text is also black. The background of the seal is white.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Donna Marie Hartnett Assistant Corporate Counsel Ivoclar Vivadent, Incorporated 175 Pineview Drive Amherst, New York 14228
9 2009
Re: K090701 Trade/Device Name: EMPRESS® DIRECT Regulation Number: 872.3690 Regulatory Class: II Product Code: EBF Dated: March 16, 2009 Received: March 26, 2009
Dear Ms. Hartnett:
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 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 (OS) regulation (21 CFR Part 820): and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2- Ms. Hartnett
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0100. 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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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 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
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Indications for Use
4090701 510(k) Number (if known):
Device Name: EMPRESS® DIRECT
Indications For Use:
Anterior restorations (Class III, IV)
Tooth Neck restorations (Class V, e.g. cervical caries, root erosion, wedge-shaped defects)
Restorations in the posterior region (Class I and II)
Direct Veneers
Corrections of tooth positions and tooth shape (e.g. diastema closure, closure of interdental "black triangles," lengthening of the incisal edge
Prescription Use V AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Anesthesiology, General Hospital
Infection Control, Dental Devices
| 510(k) Number: | K090701 |
|---|---|
| Page 1 of | ___ |
§ 872.3690 Tooth shade resin material.
(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.