Zenith Flowable Composite is a tooth-shaded resin filling material for use as an esthetic anterior restoration or base 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.
Device Story
Zenith Flowable Composite is a tooth-shaded resin filling material used by dentists for dental restorations. It functions as an esthetic restorative material for anterior teeth or as a base layer beneath other composite restorations. The material is applied directly by the clinician to the prepared tooth structure to fill cavities or provide a base, facilitating dental repair and improving esthetic outcomes for patients.
Clinical Evidence
No clinical data provided; bench testing only.
Technological Characteristics
Tooth-shaded resin-based composite material. Formulated for flowable consistency for dental restorative applications. Class II medical device.
Indications for Use
Indicated for patients requiring esthetic anterior restorations or base restorations under posterior or anterior composites. Restricted to professional use by licensed dentists.
Regulatory Classification
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.
Submission Summary (Full Text)
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850
Mr. D.T. Wolf
*Foremost Dental Manufacturing Incorporated
242 South Dean Street
Englewood, New Jersey 07631
JUL 15 1997
Re: K970683
Trade Name: Zenith Flowable Composite (Multiple)
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 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 Regulations, Title 21, Parts 800 to 895. A 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
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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 regulations.
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,
Timothy A. Ulatowski
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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K97C683/A1
Page 1 of 1
510(k) Number (if known): K970683
Device Name: Zenith Flowable Composite
Indications For Use:
Zenith Flowable Composite is a tooth-shaded resin filling material for use as an esthetic anterior restoration or base 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)
Susan Runn
(Division Sign-Off)
Division of Dental, Infection Control, and General Hospital Devices
510(k) Number K970683
Prescription Use: Yes
(For 21 CFR 801 109)
Order The-Counter Use: No
(Optional Format 1-2-96)
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