← Product Code [EJS](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EJS) · K972534 # ALFALLOY (K972534) _Aalba Dent, Inc. · EJS · Sep 5, 1997 · Dental · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EJS/K972534 ## Device Facts - **Applicant:** Aalba Dent, Inc. - **Product Code:** [EJS](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EJS.md) - **Decision Date:** Sep 5, 1997 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 872.3060 - **Device Class:** Class 2 - **Review Panel:** Dental - **Attributes:** Therapeutic ## Intended Use This device is a "white" colored, casting alloy for use in coverage onlay prosthetic devices. ## Device Story Aalba Dent "White" casting alloy; base metal alloy for dental prosthetic applications; used for coverage onlays; not compatible with dental porcelain; intended for professional dental use; provides structural material for dental restorations. ## Clinical Evidence No clinical data provided; device is a dental casting alloy subject to general controls and classification standards. ## Technological Characteristics Base metal casting alloy; Class II device; intended for dental prosthetic use; non-porcelain compatible. ## Regulatory Identification A noble metal alloy is a device composed primarily of noble metals, such as gold, palladium, platinum, or silver, that is intended for use in the fabrication of cast or porcelain-fused-to-metal crown and bridge restorations. ## Special Controls *Classification.* Class II (special controls). The special control for these devices is FDA's “Class II Special Controls Guidance Document: Dental Noble Metal Alloys.” The devices are 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}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized eagle with three stripes forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 SEP - 5 1997 Mr. Vincent Benetti General Manaqer Aalba Dent Incorporated 400 Watt Drive 94585 Cordelia, California Re: K972534 "White" Colored, Casting Alloy Trade Name: Regulatory Class: II Product Code: EJS Dated: June 30, 1997 Received: July 7, 1997 Dear Mr. Benetti: 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. ਹੈ substantially equivalent determination assumes compliance with the current Good Manufacturing Fractice requirement, 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 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. 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 {1}------------------------------------------------ Page 2 - Mr. Benetti ---- 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 leqally 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) 594-4618. 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.qov/cdrh/dsmamain.html". Sincerely yours, hv A. Ulatowski Diredtor Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radioloqical Health Enclosure {2}------------------------------------------------ Page_1________________________________________________________________________________________________________________________________________________________________________ 510(k) Number (if known): __ K972534_ Alfalloy__ Device Name : .. _ Indications for Use: -- This device is a "white" colored, casting alloy for use in This device 18 a wires on coverage onlay prosthetin According to 21 CFR Ch. 1 (4-1-89 Ed.) Part 872. devices. the classification name for this device is Base Metal Alloy, a Cla:s II device. FOR USE WITTH DENTAL PORCELAIN NOT ( PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDI:D. ) Concurrence of CDRH, Office of Device Evaluation (ODE) Susan Runser (Division Sign-Off) Division of Dental, Infection Co and General Hosp 510(k) Number Prescription Use Y (Per 21 CFR 101.109) OR Over-The Counter Use__________________________________________________________________________________________________________________________________________________________ (Optional Format 1-2-96) --- **Source:** [https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EJS/K972534](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EJS/K972534) **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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