EJS · Alloy, Other Noble Metal
Dental · 21 CFR 872.3060 · Class 2
Overview
| Product Code | EJS |
|---|---|
| Device Name | Alloy, Other Noble Metal |
| Regulation | 21 CFR 872.3060 |
| Device Class | Class 2 |
| Review Panel | Dental |
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 | BRIGHT GOLD XH | Ivoclar Vivadent, Inc. | Aug 19, 2004 | SESE |
| K040436 | SIMIDUR SUPERIOR | Wieland Dental + Technik GmbH & Co. KG | Mar 5, 2004 | SESE |
| K022252 | STERNGOLD 1, MODEL 1127781 | Sterngold | Sep 19, 2002 | SESE |
| K022469 | ECO E4 | Wieland Dental + Technik GmbH & Co. KG | Sep 18, 2002 | SESE |
| K021367 | STERNGOLD 66, MODEL #1180230 | Sterngold | May 16, 2002 | SESE |
| K020195 | SIMIDUR S1S | Wieland Dental + Technik GmbH & Co. KG | Mar 15, 2002 | SESE |
| K020194 | SIMIDUR KF PLUS | Wieland Dental + Technik GmbH & Co. KG | Mar 15, 2002 | SESE |
| K020192 | SIMIDUR S2 | Wieland Dental + Technik GmbH & Co. KG | Mar 15, 2002 | SESE |
| K014042 | D.SIGN 84 | Ivoclar Vivadent, Inc. | Feb 22, 2002 | SESE |
| K013809 | D.SIGN 59 | Ivoclar Vivadent, Inc. | Feb 7, 2002 | SESE |
| K014082 | D.SIGN 53, MODEL NA1012204 | Ivoclar Vivadent, Inc. | Jan 30, 2002 | SESE |
| K012841 | DUO PAL 6, ORDER-NO.: 2154 | Wieland Edelmetalle GmbH & Co. | Nov 20, 2001 | SESE |
| K012828 | PORTA SMK 82, MODEL 2032 | Wieland Edelmetalle GmbH & Co. | Nov 1, 2001 | SESE |
| K012840 | EURO 45, ORDER-NO.: 2064 | Wieland Edelmetalle GmbH & Co. | Oct 23, 2001 | SESE |
| K012303 | JEL-20 | J.F. Jelenko & Co., Inc. | Aug 22, 2001 | SESE |
| K003632 | DW 273 #1 | Ivoclar North America, Inc. | Dec 20, 2000 | SESE |
| K001469 | R&D PROJECT DW269#25 | Ivoclar North America, Inc. | Jul 5, 2000 | SESE |
| K000532 | JEL 15 | J.F. Jelenko & Co., Inc. | Apr 6, 2000 | SESE |
| K993475 | AUROFLUID M, ALLOY NO. 5315 | Metalor Dental USA Corp. | Dec 9, 1999 | SESE |
| K993506 | 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
