(35 days)
- Class V restorations (cervical caries, root erosion, wedge shaped defects)
- Anterior restorations (Class III and IV)
- Small posterior restorations
- Restorative therapy for mini-cavities, of all types (preparation with Sonic-Sys Micro Instruments from KaVo)
- Adhesive cementation of Sonic-Sys Inlays
- Extended fissures sealings in molars and pre-molars
- Repair of composite/ceramic veneers
- Blocking out of undercuts
- Adhesive cementation of ceramic and composite restorations
Light activated hybrid composite
I am sorry, but the provided text does not contain information about acceptance criteria or a study proving device performance. The document is a clearance letter from the FDA for a dental composite called "Light activated hybrid composite" (Trade Name: Tetric Flow), indicating it is substantially equivalent to existing devices and can be marketed.
Therefore, I cannot fulfill your request for the detailed table and study information as it is not present in the given text.
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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 3 1999
Mr. Peter P. Mancuso Requlatory/Quality Assurance Manager Ivoclar North America, Inc. 175 Pineview Drive Amherst, NY 14228
Re : K993783 Light activated hybrid composite Trade Name: Requlatory Class: II Product Code: EBF November 3, 1999 Dated: Received: November 8, 1999
Dear Mr. Mancuso:
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, qood 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 Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP 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
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Page 2 - Mr. Mancuso
obligation you might have under sections 531 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diaqnostic devices), please contact the Office of Compliance at (301) 594-4692. 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
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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CONFIDENTIAL
Image /page/2/Picture/1 description: The image shows a sequence of digits and a letter. The sequence starts with the letter 'K', followed by the digits '93703'. The characters are bold and black, contrasting with the white background. The style of the characters appears to be hand-drawn or stylized.
Page
510(k) Number (if known): |(993783
Tetric Flow Device Name:
Indications For Use:
- Class V restorations (cervical caries, root erosion, wedge shaped defects) 1
- -Anterior restorations (Class III and IV)
- Small posterior restorations -
- Restorative therapy for mini-cavities, of all types (preparation with -Sonic-Sys Micro Instruments from KaVo-)
- Adhesive cementation of Sonic-Sys Inlays
- -Extended fissures sealings in molars and pre-molars
- -Repair of composite/ceramic veneers
- । Blocking out of undercuts
- -Adhesive cementation of ceramic and composite restorations
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use_ (Per 21 CFR 801.109)
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
Susan Runner
(Division Sign-Off) Division of Dental, Infection O and General Hospital De 510(k) Number
§ 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.