(141 days)
Not Found
N/A
No
The 510(k) summary describes a dental filling material, which is a passive device and does not mention any computational or analytical capabilities.
No
The device is a tooth-shaded resin filling material used for esthetic restorations, which is generally considered a restorative or cosmetic dental material rather than a therapeutic device. It does not actively treat or prevent disease beyond restoring the physical structure of the tooth.
No
The device is described as a "tooth-shaded resin filling material," which is used for restoring teeth, not for diagnosing conditions.
No
The device description clearly states it is a "tooth-shaded resin filling material," which is a physical substance, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "esthetic anterior restoration or mase restoration under posterior or anterior composites." This describes a material used directly on the tooth for structural and aesthetic purposes.
- Device Description: The description confirms it's a "tooth-shaded resin filling material." This is a material applied to the tooth, not used to test a sample from the body.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples from the human body (blood, urine, tissue, etc.)
- Providing information about a physiological state, health, disease, or congenital abnormality.
- Being used in a laboratory setting for diagnostic purposes.
IVDs are devices used to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. Zenith Flowable Composite is a restorative material applied directly to the tooth.
N/A
Intended Use / Indications for Use
Zenith Flowable Composite is a tooth-shaded resin filling . material for use as an esthetic anterior restoration or mase restoration under posterior or anterior composites .
Product codes
EBF
Device Description
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Mentions image processing
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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
dentist, or other practitioner licensed by the law of the state in which he or she practices
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 (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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of a human figure, with three stylized profiles facing to the right. The profiles are stacked on top of each other, creating a sense of depth and dimension.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. D.T. Wolf Foremost Dental Manufacturing Incorported 242 South Dean Street Englewood, New Jersey 07631
JUL 1 5 1997
Re : K970683 Zenith Flowable Composite (Multiple) Trade Name: Regulatory Class: II Product Code: EBF Dated: May 12, 1997 Received: May 14, 1997
Dear Mr. Wolf:
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 The general controls provisions of the Act 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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਬ 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 In addition, FDA may publish further announcements action. 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. Wolf
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 requlation (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
Timothy M. Ulatowski
Timo Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
K916683/A'
Page _ of _
5 10(k) Number (il known): __ K970683
Device Name:_Zenith_Flowable_Composite
Indications I-or Usc:
Zenith Flowable Composite is a tooth-shaded resin filling . material for use as an esthetic anterior restoration or mase restoration under posterior or anterior composites .
Federal law restricts this device to sale by, or on the order of a dentist, or other practitioner licensed by the law of the state in which he or she practices to use or order the use of this device.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Suan Runner
| (Division Sign-Off) | |
|---|---|
| Division of Dental, Infection Control, and General Hospital Devices | |
| 510(k) Number | KA701683 |
| Prescription Use (Per 21 CFR 801 109) | Yes |
|---|---|
| Over-The-Counter Use (Optional Format 1-2-96) | No |
4,K-54