(43 days)
Not Found
None
No
The provided text describes a dental restorative material and its intended uses, with no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices.
No
The device is described as being used for dental restorations and corrections of tooth positions and shape, which are restorative and cosmetic procedures, not therapeutic.
No
The Intended Use/Indications for Use describe procedures for repairing and restoring teeth, such as fillings and veneers, which are therapeutic and restorative, not diagnostic.
Unknown
The provided text describes the intended use of a dental restorative material or system, not a software device. There is no mention of software, hardware, or any digital components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended uses listed are all related to the direct restoration and modification of teeth. These are procedures performed in vivo (on a living organism), not in vitro (outside the body, typically on biological samples).
- Anatomical Site: The anatomical site is the "Tooth," which is part of the living body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (like blood, urine, tissue), detecting diseases or conditions, or providing diagnostic information based on laboratory tests.
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is clearly restorative and structural, not diagnostic.
N/A
Intended Use / 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
Product codes
EBF
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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 |
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