Browse hierarchy: [Dental (DE)](/submissions/DE) → [Subpart D — Prosthetic Devices](/submissions/DE/subpart-d%E2%80%94prosthetic-devices) → [21 CFR 872.3060](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/872.3060) → EJT — Alloy, Gold-Based Noble Metal # EJT · Alloy, Gold-Based Noble Metal _Dental · 21 CFR 872.3060 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EJT ## Overview - **Product Code:** EJT - **Device Name:** Alloy, Gold-Based Noble Metal - **Regulation:** [21 CFR 872.3060](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/872.3060) - **Device Class:** 2 - **Review Panel:** [Dental](/submissions/DE) ## 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. ## Classification Rationale 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. ## 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. ## Recent Cleared Devices (20 of 627) Showing 20 most recent of 627 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K052463](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EJT/K052463.md) | PROMETAL HN86 | Prometal Technologies | Oct 14, 2005 | SESE | | [K041378](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EJT/K041378.md) | BIO 60 | Kodent, Inc. | Aug 2, 2004 | SESE | | [K040672](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EJT/K040672.md) | PORTA REFLEX | Wieland Dental + Technik GmbH & Co. KG | May 27, 2004 | SESE | | [K040524](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EJT/K040524.md) | PORTA SOLDER 1090 W | Wieland Dental + Technik GmbH & Co. KG | May 20, 2004 | SESE | | [K040043](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EJT/K040043.md) | NDX-40 ALLOY | Heraeus Kulzer, Inc. | Mar 3, 2004 | SESE | | [K034049](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EJT/K034049.md) | HERADOR EC, PF, C, H, NH, G, GG AND MP; HERALOY U AND G; HERABOND N; ALBABOND C, B AND A; BIO HERANORM | Heraeus Kulzer,GmbH | Mar 1, 2004 | SESE | | [K033279](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EJT/K033279.md) | GOLD DENTAL CASTING ALLOYS | Bego U.S.A. | Jan 15, 2004 | SESE | | [K033446](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EJT/K033446.md) | APEX93, APEX87, APEX84, APEX85, APEX77, E-SARANG 88 AND E-SARANG 82 | We Dong Myung Dental Industrial Co., Ltd. | Nov 13, 2003 | SESE | | [K033435](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EJT/K033435.md) | E-SARANG 86, DM78, DM55 | We Dong Myung Dental Industrial Co., Ltd. | Nov 12, 2003 | SESE | | [K032320](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EJT/K032320.md) | APPOLLO 3 ALLOY | Dentsply International | Oct 1, 2003 | SESE | | [K032321](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EJT/K032321.md) | CERA F ALLOY | Dentsply International | Sep 30, 2003 | SESE | | [K032319](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EJT/K032319.md) | CERA R PLUS ALLOY | Dentsply International | Sep 30, 2003 | SESE | | [K032318](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EJT/K032318.md) | MINERVA 58 ALLOY | Dentsply International | Sep 30, 2003 | SESE | | [K032317](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EJT/K032317.md) | ORION GX ALLOY | Dentsply Intl. | Sep 30, 2003 | SESE | | [K032316](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EJT/K032316.md) | ORION E ALLOY | Dentsply Intl. | Sep 30, 2003 | SESE | | [K032851](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EJT/K032851.md) | ULTRACROWN 75 ALLOY | Dentsply International | Sep 26, 2003 | SESE | | [K032715](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EJT/K032715.md) | DW 296 #15 SOLDER | Ivoclar Vivadent, Inc. | Sep 26, 2003 | SESE | | [K032267](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EJT/K032267.md) | R&D DESIGNATION AP-052-5 | Jensen Industries, Inc. | Sep 17, 2003 | SESE | | [K032493](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EJT/K032493.md) | ALEXANDER | Ivoclar Vivadent, Inc. | Sep 4, 2003 | SESE | | [K032106](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EJT/K032106.md) | STARBOND DENTAL BONDING ALLOYS | Star Refining Precious Metals South Africa | Aug 25, 2003 | SESE | ## Top Applicants - Argen Precious Metals, Inc. — 201 clearances - J.F. Jelenko & Co., Inc. — 38 clearances - Metalor Dental USA Corp. — 31 clearances - Ivoclar North America, Inc. — 29 clearances - Gateway Alloys, Inc. — 27 clearances --- **Source:** [https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EJT](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EJT) **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