EJH · Alloy, Metal, Base
Dental · 21 CFR 872.3710 · Class 2
Overview
| Product Code | EJH |
|---|---|
| Device Name | Alloy, Metal, Base |
| Regulation | 21 CFR 872.3710 |
| Device Class | Class 2 |
| Review Panel | Dental |
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 | BEGOPAL+ | Bego Bremer Goldschlaegerei Wilh. Herbst GmbH & CO | Mar 14, 2013 | SESE |
| K040180 | CONTINUM V | Aalba Dent, Inc. | Mar 4, 2004 | SESE |
| K040179 | CONTINUM | Aalba Dent, Inc. | Mar 3, 2004 | SESE |
| K033356 | VERASOFT ES | Aalba Dent, Inc. | Dec 30, 2003 | SESE |
| K033045 | DREAM BOND, DREAMCAST CHROME, DREAMCAST V, DREAM FLEXICAST, DREAM LITHECAST | American Green Dent. Mfg, Inc. | Dec 23, 2003 | SESE |
| K032136 | WIROBOND C | Bego U.S.A. | Sep 4, 2003 | SESE |
| K031627 | NANO-TICROWN | Nano-Write Corp. | Jun 11, 2003 | SESE |
| K030632 | PD CASTA-H | Mountain Medico, Inc. | May 7, 2003 | SESE |
| K030416 | CERACAST-V | Mountain Medico, Inc. | Apr 14, 2003 | SESE |
| K030161 | SUPERBOND | American Dent-All, Inc. | Mar 17, 2003 | SESE |
| K024214 | KAVO EVEREST TITANBLANK | Kavo America | Mar 12, 2003 | SESE |
| K023499 | GOLD CORE PLUS | Pentron Laboratory Technologies | Jan 13, 2003 | SESE |
| K023502 | JEWEL CAST PLUS | Pentron Laboratory Technologies | Dec 18, 2002 | SESE |
| K023477 | BIOLOY | Neirynck & Vogt NV | Dec 13, 2002 | SESE |
| K021971 | CERALOY | Neirynck & Vogt NV | Aug 1, 2002 | SESE |
| K021969 | CHROLOY | Neirynck & Vogt NV | Jul 30, 2002 | SESE |
| K021968 | CERALOY SOLDER | Neirynck & Vogt NV | Jul 26, 2002 | SESE |
| K021965 | CHROLOY SOLDER | Neirynck & Vogt NV | Jul 26, 2002 | SESE |
| K020253 | 4 ALL (DW286A) | Ivoclar Vivadent, Inc. | Apr 17, 2002 | SESE |
| K020898 | D.SIGN 15 (DW286 B) | Ivoclar Vivadent, Inc. | Mar 29, 2002 | SESE |
Top Applicants
- Aalba Dent, Inc. — 18 clearances
- Jeneric Ind. — 12 clearances
- Jeneric/Pentron, Inc. — 6 clearances
- Austenal Dental, Inc. — 6 clearances
- Williams Gold Refining Co., Inc. — 5 clearances
