(245 days)
Match Press pressable ceramic is to be used in the construction of crown substructures to be veneered with conventional porcelain. For use only by or on the order of a dental professional such as DDS or DMD. Not for use by general public or OTC.
Not Found
This document is a 510(k) premarket notification approval letter for a dental device. It does not contain information about acceptance criteria, device performance metrics, or study details as requested. The content is an FDA regulatory approval, not a scientific study report.
Therefore, I cannot provide the requested information based on the given text.
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Public Health Service
AUG 2 5 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Davis Schottlander & Davis Limited C/O Mr. Clyde E Ingersoll Official Correspondent CEI Enterprises 54 Riverview Avenue Tonawanda, New York 14150-5260
Re: K024250
Trade/Device Name: Match Press Pressable Ceramic Regulation Number: 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: II Product Code: EIH Dated: June 13, 2003 Received: June 13, 2003
Dear Mr. Ingersoll:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Mr. Ingersoll
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (301) 594-4618. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Susan Runne
Susan Runner, DDS, MA Interim Direction Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Davis Schottlander & Davis Ltd
Fifth Ave, Letchworth, Her :s SGG 2WD, England +044 (0)1462 480848 Phone: FA: (: +044 (0)1462 482802
510 (k) No K024250 ATTACHMENT #4 Schottlander Match Press pressable ceramic INDICATIONS FOR USE
Device Name: Schottlander Match Press pressable ceramic
Match Press pressable ceramic is to be used in the construction of crown substructures to be veneered with conventional porcelain.
For use only by or on the order of a dental professional such as DDS or DMD. Not for use by general public or OTC.
Kein Marley for MSR
(Division Sign-Off) Division of Anesthesiology, General Hospital. Infection Control, Dental Devices
250 510(k) Number:
Davis Schottlander & Davis Ltd
Clyde E. Ingersoll
Clyde E Ingersof Official Correspondent for Mohamed K Ladha Quality Assurance manager
§ 872.6660 Porcelain powder for clinical use.
(a)
Identification. Porcelain powder for clinical use is a device consisting of a mixture of kaolin, felspar, quartz, or other substances intended for use in the production of artificial teeth in fixed or removable dentures, of jacket crowns, facings, and veneers. The device is used in prosthetic dentistry by heating the powder mixture to a high temperature in an oven to produce a hard prosthesis with a glass-like finish.(b)
Classification. Class II.