(87 days)
Seals dentin tubulae in order to reduce post-operative sensitivity; will also improve the quality and functionality of restorations when used in conjunction with dental restoratives and cernents.
Not Found
I am sorry, but based on the provided text, there is no information about acceptance criteria or a study proving that the device meets acceptance criteria. The text provided is a 510(k) clearance letter from the FDA for a device called "Sci-Pharm Desensitizing Varnish." This letter indicates that the device has been found substantially equivalent to a predicate device and can be marketed. It does not contain details about performance studies, acceptance criteria, sample sizes, ground truth establishment, or expert involvement.
Therefore, I cannot fulfill your request for the detailed table and study information.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 7 1998
Dr. Jan A. Orlowski President Scientific Pharmaceuticals, Incorporated 3221 Producer Way Pomona, California 91768
K983305 Re : Sci-Pharm Desensitizing Varnish Trade Name: Requlatory Class: II Product Code: ГВН September 18, 1998 Dated: September 21, 1998 Received:
Dear Dr. Orlowski:
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 regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਉ 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 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.
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Page 2 - Dr. Orlowski
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) 594-4692. 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,
l'imothy ski 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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PHONE NO. : 9095950331
Image /page/2/Picture/3 description: The image shows the text "SCI-PHARM" in bold, black letters. There are two black, abstract symbols on either side of the text. The symbols appear to be stylized representations of objects, but their exact nature is unclear without further context.
SCIENTIFIC PHARMACEUTICALS, INC. 3221 Producer Way - Pomona, California USA 91768 PHONE: (909) 595-9922 · Outside California (800) 634-3047 · FAX: (909) 595-0331 E-MAIL: scipharm@msn.com - WEBSITE: http://www.scipharm.com
chemistry working for medicine and dentisiry . .
K983305 510(k) NUMBER:
Sci-Pharm Desensitizing Vamish DEVICE NAME:
. ਨੂ
INDICATIONS FOR USE:
Seals dentin tubulae in order to reduce post-operative sensitivity; will also improve the quality and functionality of restorations when used in conjunction with dental restoratives and cernents.
Susan Russo
(Division Sign-Off) (Division Sign-Christian Control, Division ral Hospital Devices
510(k) Number K918332
Manufacturers of Medical Devices. Fine Chemicals, and Pharmaceuticals
FLUOROSEAL
Image /page/2/Picture/15 description: The image shows the word "MICROJOIN" in a stylized font. The letters are bold and slightly irregular, giving the word a hand-drawn or custom appearance. There is a superscripted "(4)" to the right of the word.
Image /page/2/Picture/16 description: The image shows a black-and-white drawing of a tool with the word "C-RAY" written on it. The tool has a handle on the left side and a set of bristles on the right side. The word "C-RAY" is written in bold, sans-serif letters in the middle of the tool. There is a registered trademark symbol to the right of the word "C-RAY".
ﻟﻤﻨﺎ ﺍﻟﻤﻠﻚ ﺗﺎﺭﻳﺨﺎﻧﻴﺎ ﺗﺎﺭﻳﺨﺎﻧﻴﺎ ﻟﻠﻤﺴﺎﺣﺔ ﺍﻟﻤﺘﺤﺪﺓ ﻟﻠﺘ
§ 872.3260 Cavity varnish.
(a)
Identification. Cavity varnish is a device that consists of a compound intended to coat a prepared cavity of a tooth before insertion of restorative materials. The device is intended to prevent penetration of restorative materials, such as amalgam, into the dentinal tissue.(b)
Classification. Class II (special controls). The device, when it is an external cleaning solution, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.