EJT · Alloy, Gold-Based Noble Metal
Dental · 21 CFR 872.3060 · Class 2
Overview
| Product Code | EJT |
|---|---|
| Device Name | Alloy, Gold-Based 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 627)
Showing 20 most recent of 627 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K052463 | PROMETAL HN86 | Prometal Technologies | Oct 14, 2005 | SESE |
| K041378 | BIO 60 | Kodent, Inc. | Aug 2, 2004 | SESE |
| K040672 | PORTA REFLEX | Wieland Dental + Technik GmbH & Co. KG | May 27, 2004 | SESE |
| K040524 | PORTA SOLDER 1090 W | Wieland Dental + Technik GmbH & Co. KG | May 20, 2004 | SESE |
| K040043 | NDX-40 ALLOY | Heraeus Kulzer, Inc. | Mar 3, 2004 | SESE |
| K034049 | 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 | GOLD DENTAL CASTING ALLOYS | Bego U.S.A. | Jan 15, 2004 | SESE |
| K033446 | APEX93, APEX87, APEX84, APEX85, APEX77, E-SARANG 88 AND E-SARANG 82 | We Dong Myung Dental Industrial Co., Ltd. | Nov 13, 2003 | SESE |
| K033435 | E-SARANG 86, DM78, DM55 | We Dong Myung Dental Industrial Co., Ltd. | Nov 12, 2003 | SESE |
| K032320 | APPOLLO 3 ALLOY | Dentsply International | Oct 1, 2003 | SESE |
| K032321 | CERA F ALLOY | Dentsply International | Sep 30, 2003 | SESE |
| K032319 | CERA R PLUS ALLOY | Dentsply International | Sep 30, 2003 | SESE |
| K032318 | MINERVA 58 ALLOY | Dentsply International | Sep 30, 2003 | SESE |
| K032317 | ORION GX ALLOY | Dentsply Intl. | Sep 30, 2003 | SESE |
| K032316 | ORION E ALLOY | Dentsply Intl. | Sep 30, 2003 | SESE |
| K032851 | ULTRACROWN 75 ALLOY | Dentsply International | Sep 26, 2003 | SESE |
| K032715 | DW 296 #15 SOLDER | Ivoclar Vivadent, Inc. | Sep 26, 2003 | SESE |
| K032267 | R&D DESIGNATION AP-052-5 | Jensen Industries, Inc. | Sep 17, 2003 | SESE |
| K032493 | ALEXANDER | Ivoclar Vivadent, Inc. | Sep 4, 2003 | SESE |
| K032106 | 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
