← Product Code [EJH](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EJH) · K011706 # FLEXICAST PRIME (K011706) _American Dent-All, Inc. · EJH · Aug 6, 2001 · Dental · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EJH/K011706 ## Device Facts - **Applicant:** American Dent-All, Inc. - **Product Code:** [EJH](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EJH.md) - **Decision Date:** Aug 6, 2001 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 872.3710 - **Device Class:** Class 2 - **Review Panel:** Dental ## Indications for Use Flexicast Prime ( Partial Denture Dental Casting Alloy ) is for use in dental laboratories, suitable for preparation of removable dental appliances. ## Device Story Flexicast Prime is a dental casting alloy used in dental laboratories for the fabrication of removable dental appliances. The device is a material intended for use by dental laboratory technicians to cast dental prosthetics. It functions as a structural component for dental restorations. No clinical data or complex software/algorithms are involved. ## Clinical Evidence No clinical data provided; bench testing only. ## Technological Characteristics Dental casting alloy for removable dental appliances. Class II device (Product Code: EJH). ## Regulatory Identification A base metal alloy is a device composed primarily of base metals, such as nickel, chromium, or cobalt, that is intended for use in fabrication of cast or porcelain-fused-to-metal crown and bridge restorations. ## Special Controls *Classification.* Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Dental Base Metal Alloys.” The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9. See § 872.1(e) for availability of guidance information. ## 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}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a series of flowing lines. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 AUG - 6 2001 Mr. Vachakan H. Khoie President American Dent-All Incorporated 5140 San Fernando Road Glendale, California 91204 Re : K011706 Trade/Device Name: Flexicast Prime Regulation Number: 872.3710 Requlatory Class: II Product Code: EJH Dated: June 1, 2001 Received: June 4, 2001 Dear Mr. Khoie: 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 reqistration, 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. 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 requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. {1}------------------------------------------------ Page 2 - Mr. Khoie 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 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 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" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained 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, Tim Allen A. Ulatowski y A. Ulatowski Tim Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radioloqical Health Enclosure {2}------------------------------------------------ Image /page/2/Picture/0 description: The image shows a logo with the words "THE GREAT HALL" arranged in a circular pattern at the top. Below the text, there are several vertical lines of varying lengths, with three curved lines on the right side of the vertical lines. The logo appears to be stylized and possibly distressed, with a vintage or worn look. K011706 ## INDICATION FOR USE ## Device Name: Flexicast Prime Flexicast Prime ( Partial Denture Dental Casting Alloy ) is for use in dental laboratories, suitable for preparation of removable dental appliances. Swan Runge (Division Sign-Off) Division of Dental, Infection Control, and General Hospital Device 10:1 Number _ EOL 5 401 San Semanto Itt Globolo, DA (1204 E.C.A., - IoR Fivor (177) 804-6299 - Tal. (818) 662-0619 c mail: amerident all@carilnink net --- **Source:** [https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EJH/K011706](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EJH/K011706) **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. If you're preparing [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/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com