EJJ · Alloy, Amalgam
Dental · 21 CFR 872.3070 · Class 2
Overview
| Product Code | EJJ |
|---|---|
| Device Name | Alloy, Amalgam |
| Regulation | 21 CFR 872.3070 |
| Device Class | Class 2 |
| Review Panel | Dental |
| 3rd-Party Reviewable | Yes |
Identification
Dental amalgam is a device that consists of a combination of elemental mercury, supplied as a liquid in bulk, sachet, or predosed capsule form, and amalgam alloy composed primarily of silver, tin, and copper, supplied as a powder in bulk, tablet, or predosed capsule form, for the direct filling of carious lesions or structural defects in teeth. This device also includes the individual component devices, mercury and amalgam alloy, when intended to be combined with each other to form dental amalgam.
Classification Rationale
Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Dental Amalgam, Mercury, and Amalgam Alloy.” See § 872.1(e) for the availability of this guidance document.
Special Controls
*Classification.* Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Dental Amalgam, Mercury, and Amalgam Alloy.”*See* § 872.1(e) for the availability of this guidance document.
Recent Cleared Devices (20 of 74)
Showing 20 most recent of 74 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K053114 | SILVERFIL | Dunia Perwira Manufacturing Sdn. Bhd. | Nov 15, 2005 | SESE |
| K051010 | SECURALLOY, SEPTALLOY NG 50 AND SEPTALLOY NG 70 | Septodont | May 2, 2005 | SESE |
| K033434 | BESTALOY | We Dong Myung Dental Industrial Co., Ltd. | Nov 12, 2003 | SESE |
| K032152 | BENCO ADMIX | Southern Dental Industries, Inc. | Aug 6, 2003 | SESE |
| K031658 | BENCO SPHERICAL | Southern Dental Industries, Inc. | Jul 29, 2003 | SESE |
| K020452 | HIGH SILVER CONVENTIONAL | Ab Ardent | May 7, 2002 | SESE |
| K011801 | FUTURA TOPCAP NON GAMMA-2 | Ab Ardent | Aug 16, 2001 | SESE |
| K002811 | ANA 70 NON GAMMA 2 DISPERSED PHASE DENTAL ALLOY | Nordiska Dental AB | Oct 31, 2000 | SESE |
| K002810 | ANA 3000 SM NON GAMMA 2 MODIFIED SPHERICAL DENTAL ALLOY | Nordiska Dental AB | Oct 31, 2000 | SESE |
| K002808 | ANA 2000 NON GAMMA 2 EXTRA HIGH COPPER DENTAL ALLOY | Nordiska Dental AB | Oct 31, 2000 | SESE |
| K991481 | PARAGON | Lancer Orthodontics, Inc. | Aug 11, 1999 | SESE |
| K982671 | SECURALLOY | Specialites Septodont | Oct 19, 1998 | SESE |
| K982460 | VIVACAP HR | Ab Ardent | Aug 24, 1998 | SESE |
| K982458 | VIVALLOY HR | Ab Ardent | Aug 24, 1998 | SESE |
| K982456 | AMALCAP PLUS | Ab Ardent | Aug 24, 1998 | SESE |
| K974035 | CENTURY ALLOY | Dentsply Intl. | Dec 17, 1997 | SESE |
| K973086 | PLA-96P | Southern Dental Industries, Inc. | Oct 7, 1997 | SESE |
| K973088 | PLS-96P | Southern Dental Industries, Inc. | Oct 3, 1997 | SESE |
| K964192 | ARDENT NON GAMMA-2 70 | Ardent Production Development | Jan 6, 1997 | SESE |
| K964775 | ARDENT FUTURA NON GAMMA-2 | Ardent Production Development | Dec 10, 1996 | SESE |
Top Applicants
- Southern Dental Industries, Inc. — 6 clearances
- Ab Ardent — 5 clearances
- Goldsmith & Revere, Inc. — 4 clearances
- Ivoclar North America, Inc. — 4 clearances
- Degussa AG — 3 clearances
