← Product Code [EBF](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBF) · K982201 # ZENITH LUXACORE AUTOMIX CORE MATERIAL (MULTIPLE) (K982201) _Foremost Dental Mfg., Inc. · EBF · Aug 10, 1998 · Dental · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBF/K982201 ## Device Facts - **Applicant:** Foremost Dental Mfg., Inc. - **Product Code:** [EBF](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBF.md) - **Decision Date:** Aug 10, 1998 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 872.3690 - **Device Class:** Class 2 - **Review Panel:** Dental - **Attributes:** Therapeutic ## Intended Use Core material- when a tooth is fractured a Technique called Post and core is used to restore functum. A post is cemented into the endo dentically Treated tooth. A core material is used to build up around the tooth and post so that a finished appliance can be placed. ## Device Story Zenith LuxaCore Automix is a dental core build-up material. It is used by dentists in a clinical setting to restore fractured, endodontically treated teeth. The material is applied around a cemented post to create a core foundation, allowing for the subsequent placement of a final dental restoration (e.g., crown). The device is supplied in an automix delivery system, facilitating consistent mixing and direct application to the tooth structure. It functions as a restorative material to rebuild tooth anatomy, enabling the patient to regain dental function. ## Clinical Evidence No clinical data provided; substantial equivalence is based on bench-level assessment of the material's intended use and characteristics. ## Technological Characteristics Dental core build-up material; automix delivery system; chemical composition typical of dental restorative resins; intended for intraoral use. ## Regulatory 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) > 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 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. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 AUG 1 0 1998 Mr. D. Tim Wolf ·Vice President Foremost Dental Manufacturing, Incorporated 242 South Dean Street Englewood, New Jersey 07631 Re : K982201 Zenith LuxaCore Automix Core Material Trade Name: (Multiple) Requlatory Class: I Product Code: EBF Dated: June 22, 1998 Received: June 22, 1998 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 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). 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 aqainst 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. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, 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 Druq 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 Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 {1}------------------------------------------------ Page 2 - Mr. Wolf through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations. 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) 594-4692. 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 requlation entitled, "Misbranding by reference to premarket notification" (21CFR 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/dsma/dsmamain.html". Sincerely yours, S. Autman for Timothy A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radioloqical Health Enclosure .... ........ {2}------------------------------------------------ FDA/ODE/DDIGD S10(k) Number (if known): K982201 Device Name: Luxe core Indications For Use: - Core material- when a tooth is fractured a Technique called Post and core is used to restore functum. A post is cemented into the endo dentically Treated tooth. A core material is used to build up around the tooth and post so that a finished appliance can be placed. (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODB) Susan Rumm (Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number escription Use 2er 21 CFR 801.109) O O OR Over-The-Counter Use ী ০০ 2 (Optional Forms! 1-2-96) --- **Source:** [https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBF/K982201](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBF/K982201) **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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