(81 days)
No
The summary does not mention AI, ML, image processing, or any other indicators of AI/ML technology.
No
The intended use states it is for restoration of dental structures, which is a restorative rather than therapeutic function.
No
Explanation: The "Intended Use / Indications for Use" states that the device is used for "repair" and "restoration" of dental conditions. This suggests a therapeutic or restorative function, not a diagnostic one (identifying or characterizing a disease or condition).
No
The summary describes a "system" used for "repairing ceramic and intettil oond Vestoration S dental". This language strongly suggests a physical device or kit is involved in the repair process, not solely software. The lack of any mention of software, algorithms, or data processing further supports this conclusion.
Based on the provided information, it is highly unlikely that this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is described as "The and repair cerainic and intettil oond Vestoration S dental". This clearly indicates a use related to dental procedures performed on a patient, not on a sample taken from a patient.
- Anatomical Site: The anatomical site is "dental", which further supports a direct interaction with the patient's mouth.
- Lack of IVD Indicators: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), 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 the diagnosis, prevention, monitoring, treatment, or alleviation of disease. The description of the Silver System does not align with this definition.
Therefore, based on the available information, the Silver System appears to be a dental device used for restoration and repair, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Silver system is a system used to The and repair cerainic and intettil oond Vestoration S dental
Product codes
EBF, KOJ, KLE
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
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Not Found
Key Metrics
Not Found
Predicate Device(s)
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ms. Lindsay Tilton Regulatory Affairs Danville Materials, Incorporated 3420 Fostoria Way, Suite, A-200 San Ramon, California 94583
Re: K110642
Trade/Device Name: SilJet System Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Codes: EBF, KOJ and KLE Dated: February 3, 2011 Received: March 7, 2011
Dear Ms. Tilton:
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-generalcontrols 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.
MAY 2-7-2011
1
Page 2 - Ms. Tilton
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/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 Punser
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
2
Indications for Use Form
Indications for Use 0642 510(k) Number (if known): SilJet System Device Name:
Indications for Use:
Silver system is a system used to The and repair cerainic and intettil oond Vestoration S dental
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Qffice of Device Evaluation (ODE)
Susan Turner
(Division Sign-Off) (Division Sign Only infection Control, Dental Devices
510(k) Number: K101402
| Page | _ | of | _ |
|---|---|---|---|
| ------ | --- | ---- | --- |