(141 days)
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.
Zenith Flowable Composite is a tooth-shaded resin filling material.
The provided text is a 510(k) premarket notification letter from the FDA to a dental device manufacturer. It confirms the substantial equivalence of the "Zenith Flowable Composite" to a legally marketed predicate device.
This document does NOT contain information about acceptance criteria, device performance studies, or the methodologies used to establish ground truth or conduct clinical trials.
Therefore, I cannot answer your request for the following reasons:
- No acceptance criteria or device performance data is present. The letter is a regulatory approval and does not detail performance metrics.
- No study information is provided. It does not describe any clinical trials, validation studies, or the data collected from such studies.
- No ground truth establishment methods are mentioned.
- No information on sample sizes, expert qualifications, or adjudication methods is available.
- No details on standalone performance or MRMC studies are included.
- No training set information is provided.
The document is purely administrative, confirming the device's marketability based on its substantial equivalence to a pre-existing device. If your query relates to the regulatory process for proving substantial equivalence, then the document confirms that the device was deemed substantially equivalent based on information submitted in the 510(k) application (K970683). However, it does not provide the specifics of that information regarding performance studies.
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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
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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
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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
§ 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.