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) → EJS — Alloy, Other Noble Metal # EJS · Alloy, Other Noble Metal _Dental · 21 CFR 872.3060 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EJS ## Overview - **Product Code:** EJS - **Device Name:** Alloy, Other 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 194) Showing 20 most recent of 194 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K041433](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EJS/K041433.md) | BRIGHT GOLD XH | Ivoclar Vivadent, Inc. | Aug 19, 2004 | SESE | | [K040436](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EJS/K040436.md) | SIMIDUR SUPERIOR | Wieland Dental + Technik GmbH & Co. KG | Mar 5, 2004 | SESE | | [K022252](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EJS/K022252.md) | STERNGOLD 1, MODEL 1127781 | Sterngold | Sep 19, 2002 | SESE | | [K022469](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EJS/K022469.md) | ECO E4 | Wieland Dental + Technik GmbH & Co. KG | Sep 18, 2002 | SESE | | [K021367](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EJS/K021367.md) | STERNGOLD 66, MODEL #1180230 | Sterngold | May 16, 2002 | SESE | | [K020195](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EJS/K020195.md) | SIMIDUR S1S | Wieland Dental + Technik GmbH & Co. KG | Mar 15, 2002 | SESE | | [K020194](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EJS/K020194.md) | SIMIDUR KF PLUS | Wieland Dental + Technik GmbH & Co. KG | Mar 15, 2002 | SESE | | [K020192](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EJS/K020192.md) | SIMIDUR S2 | Wieland Dental + Technik GmbH & Co. KG | Mar 15, 2002 | SESE | | [K014042](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EJS/K014042.md) | D.SIGN 84 | Ivoclar Vivadent, Inc. | Feb 22, 2002 | SESE | | [K013809](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EJS/K013809.md) | D.SIGN 59 | Ivoclar Vivadent, Inc. | Feb 7, 2002 | SESE | | [K014082](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EJS/K014082.md) | D.SIGN 53, MODEL NA1012204 | Ivoclar Vivadent, Inc. | Jan 30, 2002 | SESE | | [K012841](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EJS/K012841.md) | DUO PAL 6, ORDER-NO.: 2154 | Wieland Edelmetalle GmbH & Co. | Nov 20, 2001 | SESE | | [K012828](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EJS/K012828.md) | PORTA SMK 82, MODEL 2032 | Wieland Edelmetalle GmbH & Co. | Nov 1, 2001 | SESE | | [K012840](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EJS/K012840.md) | EURO 45, ORDER-NO.: 2064 | Wieland Edelmetalle GmbH & Co. | Oct 23, 2001 | SESE | | [K012303](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EJS/K012303.md) | JEL-20 | J.F. Jelenko & Co., Inc. | Aug 22, 2001 | SESE | | [K003632](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EJS/K003632.md) | DW 273 #1 | Ivoclar North America, Inc. | Dec 20, 2000 | SESE | | [K001469](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EJS/K001469.md) | R&D PROJECT DW269#25 | Ivoclar North America, Inc. | Jul 5, 2000 | SESE | | [K000532](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EJS/K000532.md) | JEL 15 | J.F. Jelenko & Co., Inc. | Apr 6, 2000 | SESE | | [K993475](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EJS/K993475.md) | AUROFLUID M, ALLOY NO. 5315 | Metalor Dental USA Corp. | Dec 9, 1999 | SESE | | [K993506](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EJS/K993506.md) | PAGALINOR 4 , ALLOY NO. 5440 | Metalor Dental USA Corp. | Dec 8, 1999 | SESE | ## Top Applicants - Metalor Dental USA Corp. — 31 clearances - Deringer-Ney, Inc. — 14 clearances - Ivoclar North America, Inc. — 12 clearances - J.F. Jelenko & Co., Inc. — 11 clearances - Degussa Dental, Inc. — 10 clearances --- **Source:** [https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EJS](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EJS) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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