Browse hierarchy: [Dental (DE)](/submissions/DE) → [Subpart D — Prosthetic Devices](/submissions/DE/subpart-d%E2%80%94prosthetic-devices) → [21 CFR 872.3710](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/872.3710) → EJH — Alloy, Metal, Base # EJH · Alloy, Metal, Base _Dental · 21 CFR 872.3710 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EJH ## Overview - **Product Code:** EJH - **Device Name:** Alloy, Metal, Base - **Regulation:** [21 CFR 872.3710](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/872.3710) - **Device Class:** 2 - **Review Panel:** [Dental](/submissions/DE) ## 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. ## Classification Rationale 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. ## 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. ## Recent Cleared Devices (20 of 153) Showing 20 most recent of 153 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K123929](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EJH/K123929.md) | BEGOPAL+ | Bego Bremer Goldschlaegerei Wilh. Herbst GmbH & CO | Mar 14, 2013 | SESE | | [K040180](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EJH/K040180.md) | CONTINUM V | Aalba Dent, Inc. | Mar 4, 2004 | SESE | | [K040179](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EJH/K040179.md) | CONTINUM | Aalba Dent, Inc. | Mar 3, 2004 | SESE | | [K033356](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EJH/K033356.md) | VERASOFT ES | Aalba Dent, Inc. | Dec 30, 2003 | SESE | | [K033045](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EJH/K033045.md) | DREAM BOND, DREAMCAST CHROME, DREAMCAST V, DREAM FLEXICAST, DREAM LITHECAST | American Green Dent. Mfg, Inc. | Dec 23, 2003 | SESE | | [K032136](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EJH/K032136.md) | WIROBOND C | Bego U.S.A. | Sep 4, 2003 | SESE | | [K031627](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EJH/K031627.md) | NANO-TICROWN | Nano-Write Corp. | Jun 11, 2003 | SESE | | [K030632](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EJH/K030632.md) | PD CASTA-H | Mountain Medico, Inc. | May 7, 2003 | SESE | | [K030416](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EJH/K030416.md) | CERACAST-V | Mountain Medico, Inc. | Apr 14, 2003 | SESE | | [K030161](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EJH/K030161.md) | SUPERBOND | American Dent-All, Inc. | Mar 17, 2003 | SESE | | [K024214](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EJH/K024214.md) | KAVO EVEREST TITANBLANK | Kavo America | Mar 12, 2003 | SESE | | [K023499](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EJH/K023499.md) | GOLD CORE PLUS | Pentron Laboratory Technologies | Jan 13, 2003 | SESE | | [K023502](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EJH/K023502.md) | JEWEL CAST PLUS | Pentron Laboratory Technologies | Dec 18, 2002 | SESE | | [K023477](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EJH/K023477.md) | BIOLOY | Neirynck & Vogt NV | Dec 13, 2002 | SESE | | [K021971](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EJH/K021971.md) | CERALOY | Neirynck & Vogt NV | Aug 1, 2002 | SESE | | [K021969](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EJH/K021969.md) | CHROLOY | Neirynck & Vogt NV | Jul 30, 2002 | SESE | | [K021968](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EJH/K021968.md) | CERALOY SOLDER | Neirynck & Vogt NV | Jul 26, 2002 | SESE | | [K021965](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EJH/K021965.md) | CHROLOY SOLDER | Neirynck & Vogt NV | Jul 26, 2002 | SESE | | [K020253](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EJH/K020253.md) | 4 ALL (DW286A) | Ivoclar Vivadent, Inc. | Apr 17, 2002 | SESE | | [K020898](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EJH/K020898.md) | D.SIGN 15 (DW286 B) | Ivoclar Vivadent, Inc. | Mar 29, 2002 | SESE | ## Top Applicants - Aalba Dent, Inc. — 18 clearances - Jeneric Ind. — 12 clearances - Austenal Dental, Inc. — 6 clearances - Jeneric/Pentron, Inc. — 6 clearances - American Dent-All, Inc. — 5 clearances --- **Source:** [https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EJH](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EJH) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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