← Product Code [EIH](/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EIH) · K024252 # MATCH MASTER LOW FUSION PORCELAIN (K024252) _Davis Schottlander & Davis, Ltd. · EIH · Jan 22, 2004 · Dental · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EIH/K024252 ## Device Facts - **Applicant:** Davis Schottlander & Davis, Ltd. - **Product Code:** [EIH](/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EIH.md) - **Decision Date:** Jan 22, 2004 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 872.6660 - **Device Class:** Class 2 - **Review Panel:** Dental ## Indications for Use Match Master low fusing porcelain is to be used in conjunction with metal or pressable ceramic framework in the construction of crowns and/or bridgework. ## Device Story Schottlander MATCH MASTER is a low-fusing porcelain powder used by dental technicians in laboratory settings. It is applied to metal or pressable ceramic frameworks to construct dental crowns and bridges. The device functions as a restorative dental material, providing the aesthetic and functional outer layer for prosthetic dental restorations. It is intended for prescription use only. ## Clinical Evidence No clinical data provided; bench testing only. ## Technological Characteristics Low-fusing porcelain powder for dental prosthetic applications. Classified as Class II medical device under 21 CFR 872.6660. ## Regulatory 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. ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo consists of a stylized depiction of an eagle or bird with three wing-like shapes, representing the department's mission of promoting health and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the bird symbol. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 JAN 2 2 2004 Davis Schottlander & Davis Limited C/O Mr. Clyde E. Ingersoll CEI Enterprises 54 Riverview Avenue Tonawanda, New York 14150-5260 Re: K024252 Trade/Device Name: Schottlander MATCH MASTER Low Fusing Porcelain Regulation Number: 872.6660 Regulation Name: Porcelain Powder for Clinical use Regulatory Class: II Product Code: EIH Dated: November 24, 2003 Received: November 28, 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. {1}------------------------------------------------ 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. or the ret 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) 594-4613. 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 vours, Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number: k024252 Device Name: Schottlander MATCH MASTER Low fusing porcelain Indications for Use Match Master low fusing porcelain is to be used in conjunction with metal or pressable ceramic framework in the construction of crowns and/or bridgework. Prescription Use _ X (Part 21 CFR801 Subpart D) AND/OR Over-the-counter Use (Part 21 CFR807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED) concurrence of CDRH, Office of Device Evaluation (ODE) Susan Rump (Division Sign-Off) (Division Oigh Oly), General Hospital, Infection Control, Dental Devices KU202 Page 1 of ____________________________________________________________________________________________________________________________________________________________________ 510(k) Number --- **Source:** [https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EIH/K024252](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EIH/K024252) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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