(132 days)
Not Found
Not Found
No
The summary describes a dental composite material and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
No
Solidex is a dental composite material used for constructing restorations like crowns and bridges, not a device that directly treats a disease or condition for therapeutic purposes. It's a material used in a therapeutic procedure.
No
Explanation: The device, Solidex, is described as a "light cured, hard crown and bridge composite" used for "construction of crowns and bridges" and various dental restorations. Its intended use is for fabrication and restoration, not for diagnosing conditions or diseases.
No
The device description clearly states it is a "light cured, hard crown and bridge composite," which is a physical material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device as a dental composite material used for constructing dental restorations like crowns, bridges, veneers, etc. This is a material used in the mouth for structural purposes.
- Device Description: The description confirms it's a light-cured composite for dental restorations.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens in vitro (outside the body) to provide information about a physiological state, health, or disease. IVDs typically involve analyzing samples like blood, urine, tissue, etc.
Therefore, Solidex is a dental restorative material, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Solidex is a light cured, hard crown and bridge composite. It is suitable for use in the construction of crowns and bridges, telescopic and cone crowns, attachment work, implant restoration, facings, jacket crowns, inlays and onlays, long-term provisionals, and veneers. It is universal product suitable for all classes of reconstructions, provided it is supported by adequated by working framework.
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
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)
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 Department of Health & Human Services (HHS) of the United States. The seal features the department's name encircling a stylized image of three human profiles facing right. The profiles are stacked vertically, with the top profile being the most prominent and the bottom profile being the least prominent. The seal is black and white.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Hideaki Kumazawa ·Shofu Dental Corporation 4025 Bohannon Drive Menlo Park, California 94025
OCT 2 9 1997
K972292 Re: Trade Name: Solidex Regulatory Class: II Product Code: EBF Dated: August 15, 1997 Received: August 27; 1997 --
Dear Mr. Kumazawa:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਸੀ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531
1
Page 2 - Mr. Kumazawa
through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
This letter will allow you to begin marketing your device as described in your 510 (k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
K. Allworth
Timothy A. II atowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
. Enclosure
2
Indication for Use
Solidex is a light cured, hard crown and bridge composite. It is suitable for use in the construction of crowns and bridges, telescopic and cone crowns, attachment work, implant restoration, facings, jacket crowns, inlays and onlays, long-term provisionals, and veneers. It is universal product suitable for all classes of reconstructions, provided it is supported by adequated by working framework.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Sueen tum
(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number ka 7030
Prescription Use S (Per 21CFR§801 (109) OR
Over-The-Counter Use No