← Product Code [EJH](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EJH) · K970205 # VITALLIUM 2000 ALLOY; VITALLIUM 2000 PLUS ALLOY; COBALT CHROME CASTING ALLOY (K970205) _Austenal, Inc. · EJH · Apr 21, 1997 · Dental · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EJH/K970205 ## Device Facts - **Applicant:** Austenal, Inc. - **Product Code:** [EJH](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EJH.md) - **Decision Date:** Apr 21, 1997 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 872.3710 - **Device Class:** Class 2 - **Review Panel:** Dental - **Attributes:** Therapeutic ## Indications for Use The above name products are intended for use as base metal casting alloys for casting removable partial denture frameworks. ## Device Story Base metal casting alloys (Vitallium 2000, Vitallium 2000 Plus, Cobalt Chrome Casting Alloy) used by dental laboratory technicians to cast removable partial denture frameworks. Alloys melted and cast into molds to create prosthetic structures. Provides structural support and durability for dental restorations. Clinical benefit includes restoration of oral function and aesthetics for patients requiring partial dentures. ## Clinical Evidence No clinical data. Substantial equivalence is based on bench testing of compositional and mechanical properties (yield strength and elongation) compared to established ISO and ANSI/ADA standards. ## Technological Characteristics Cobalt-chrome based casting alloys. Composition: Cobalt, Chromium, Molybdenum (≥ 85%). Mechanical properties: 0.2% Yield Strength ≥ 500 MPa; % Elongation ≥ 3%. Complies with ISO 6871 (Base Metal Casting Alloys - Part I Cobalt Based Alloys) and ANSI/ADA Standard Specification #14. ## 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. ## Predicate Devices - Vitallium Alloy ([K880875](/device/K880875.md)) - Vitallium 2 Alloy ([K880875](/device/K880875.md)) - Vitallium Equipoise Alloy ([K880875](/device/K880875.md)) ## 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} A AUSTENAL APR 21 1997 4101 W. 51ST STREET CHICAGO, IL 60632-4287 TEL 312.735.0600 800.621.0381 FAX 312.735.3940 K970205 # 510 (K) Notification Summary Attachment # 1 Pre-market Notification: K970205 Submitter's Name: Austenal, Inc. 4101 W. 51st Street Chicago, IL. Telephone: 773-735-0600 Fax: 773-735-3940 Contact Person: Ronald Dudek Date of Filing: March 31, 1997 Trade Names of Alloy: 1) Vitallium 2000 Alloy 2) Vitallium 2000 Plus Alloy 3) Cobalt Chrome Casting Alloy Signature: ![img-0.jpeg](img-0.jpeg) The above name products are intended for use as base metal casting alloys for casting removable partial denture frameworks. These products are part of a class of materials called base metal casting alloys. Substantially, equivalent products for these products are preammendment devices Vitallium Alloy, Vitallium 2 Alloy, and Vitallium Equipoise Alloy cover by 510 (K) Notification K 880875. Vitallium 2000 Alloy, Vitallium 2000 Plus Alloy, Cobalt Chrome Casting Alloy, and the predicate products comply with the compositional and mechanical property requirements of ISO Product Standard: ISO 6871, Base Metal Casting Alloys- Part I Cobalt Based Alloys and ANSI/ADA Standard Specification ANSI/ADA # 14 Base Metal Casting Alloys. ## Composition Requirements | Cobalt + Chromium + Molybdenum | ≥ 85% | | --- | --- | | Vitallium Alloy | 98.1% | | Vitallium 2 Alloy | 98.0% | | Vitallium Equipoise Alloy | 98.1% | | Vitallium 2000 Alloy | 98.3% | | Vitallium 2000 Plus Alloy | 98.0% | | Cobalt Chrome Casting Alloy | 97.5% | ## Mechanical Property Requirements | | 0.2% Yield Strength | % Elongation | | --- | --- | --- | | ISO/ANSI/ADA Requirement | ≥ 500 MPa | ≥ 3% | | Vitallium Alloy | 616 | 4.5 | | Vitallium 2 Alloy | 551 | 9.6 | | Vitallium Equipoise Alloy | 585 | 3.0 | | Vitallium 2000 Alloy | 609 | 8.9 | | Vitallium 2000 Plus Alloy | 690 | 19.5 | | Cobalt Chrome Casting Alloy | 555 | 6.0 | Instructions and labels for these products also complies with the ISO and ANSI/ADA standards guidelines. {1} 4101 W. 51ST STREET CHICAGO, IL 60632-4287 TEL 312.735.0600 800.621.0381 FAX 312.735.3940 # AUSTENAL ## Base Metal Casting Alloys ### 510(k) Notification Summary The family of Base Metal Casting Alloys are cobalt chrome casting alloys substantially equivalent to the alloys currently used to produce partial denture frameworks. Alloys of this type are used extensively in the fabrication of partial dentures and have histories of excellent clinical performance and also complies with ANSI/American Dental Association Specification No. 14 for Base Metal Alloys and ISO 6871 Part 1 for Base Metal Casting Alloys- Cobalt Based. --- **Source:** [https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EJH/K970205](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EJH/K970205) **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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