Alloy, Amalgam
Regulation 872.3070
0510(k)s in 12 months (74 all time)
0recalls in 12 months (2 all time)
2recalls that name a 510(k)
Top companies in EJJ
| Company | 510(k)s | Recalls |
|---|---|---|
| Southern Dental Industries, Inc. | 6 | 0 |
| Ab Ardent | 5 | 0 |
| Goldsmith & Revere, Inc. | 4 | 0 |
| Ivoclar North America, Inc. | 4 | 0 |
| Degussa AG | 3 | 0 |
| Jeneric/Pentron, Inc. | 3 | 0 |
| Johnson & Johnson Professionals, Inc. | 3 | 0 |
| Kerr Corporation (Danbury) | 3 | 0 |
| Nordiska Dental AB | 3 | 0 |
| Ardent Production Development | 2 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 15, 2005 | K053114 | SILVERFIL Dunia Perwira Manufacturing Sdn. Bhd., MY | EJJ |
| May 2, 2005 | K051010 | SECURALLOY, SEPTALLOY NG 50 AND SEPTALLOY NG 70 Septodont | EJJ |
| Nov 12, 2003 | K033434 | BESTALOY We Dong Myung Dental Industrial Co., Ltd. | EJJ |
| Aug 6, 2003 | K032152 | BENCO ADMIX Southern Dental Industries, Inc. | EJJ |
| Jul 29, 2003 | K031658 | BENCO SPHERICAL Southern Dental Industries, Inc. | EJJ |
| May 7, 2002 | K020452 | HIGH SILVER CONVENTIONAL Ab Ardent | EJJ |
| Aug 16, 2001 | K011801 | FUTURA TOPCAP NON GAMMA-2 Ab Ardent | EJJ |
| Oct 31, 2000 | K002811 | ANA 70 NON GAMMA 2 DISPERSED PHASE DENTAL ALLOY Nordiska Dental AB | EJJ |
| Oct 31, 2000 | K002810 | ANA 3000 SM NON GAMMA 2 MODIFIED SPHERICAL DENTAL ALLOY Nordiska Dental AB | EJJ |
| Oct 31, 2000 | K002808 | ANA 2000 NON GAMMA 2 EXTRA HIGH COPPER DENTAL ALLOY Nordiska Dental AB | EJJ |
| Aug 11, 1999 | K991481 | PARAGON Lancer Orthodontics, Inc. | EJJ |
| Oct 19, 1998 | K982671 | SECURALLOY Specialites Septodont | EJJ |
| Aug 24, 1998 | K982460 | VIVACAP HR Ab Ardent | EJJ |
| Aug 24, 1998 | K982458 | VIVALLOY HR Ab Ardent | EJJ |
| Aug 24, 1998 | K982456 | AMALCAP PLUS Ab Ardent | EJJ |
| Dec 17, 1997 | K974035 | CENTURY ALLOY Dentsply Intl. | EJJ |
| Oct 7, 1997 | K973086 | PLA-96P Southern Dental Industries, Inc. | EJJ |
| Oct 3, 1997 | K973088 | PLS-96P Southern Dental Industries, Inc. | EJJ |
| Jan 6, 1997 | K964192 | ARDENT NON GAMMA-2 70 Ardent Production Development | EJJ |
| Dec 10, 1996 | K964775 | ARDENT FUTURA NON GAMMA-2 Ardent Production Development | EJJ |
| Jan 24, 1996 | K955285 | GALLOY Southern Dental Industries, Inc. | EJJ |
| Aug 25, 1995 | K952670 | CUPRALLOY Wykle Research, Inc. | EJJ |
| Jun 6, 1995 | K951663 | TYTIN R Kerr Corporation (Danbury) | EJJ |
| May 25, 1995 | K951865 | ULTRA SPHERICAL AMALGAM ALLOY Goldsmith & Revere, Inc. | EJJ |
| May 2, 1995 | K951511 | TYTIN ADMIX Kerr Corporation (Danbury) | EJJ |
| Jul 14, 1994 | K942430 | AGALLOY, DISALLOY, EPSILON AND LAMBDA Fen Dental Mfg., Inc. | EJJ |
| Apr 29, 1994 | K940675 | SYBRALOY Sybron Dental Specialties, Inc. | EJJ |
| Mar 11, 1994 | K935535 | TYTIN Kerr Corporation (Danbury) | EJJ |
| Feb 10, 1994 | K936113 | INDIPERSE Indisperse Distributing, Inc. | EJJ |
| Oct 1, 1993 | K933309 | PRINCE Goldsmith & Revere, Inc. | EJJ |
| Mar 15, 1993 | K922100 | DISPOSABLE TURP FLUID CONTAINMENT DRAPE - STERILE Graham Medical Products | EJJ |
| Feb 12, 1993 | K923640 | GK DENTAL AMALGAM ALLOY The Patron Trading Corp. | EJJ |
| Jan 11, 1993 | K923384 | ANA 70 DISPERSED PHASE DENTAL ALLOY -- MODIFIED L.C. Dental | EJJ |
| Aug 10, 1992 | K921538 | AMALGAPHASE Saskan Amalgam Alloys, Inc. | EJJ |
| Mar 2, 1992 | K915654 | KERALLOY-D CAPS Wilde-USA, Inc. | EJJ |
| Dec 27, 1991 | K913175 | MIRACLE MIX CAPS GLASS IONOMER CEMENT INCAPSULES G-C Intl. Corp. | EJJ |
| Nov 13, 1991 | K912992 | KERALLOY NON-GAMMA 2 AMALGAM Wilde-USA, Inc. | EJJ |
| Mar 29, 1991 | K905204 | DW 236 Ivoclar North America, Inc. | EJJ |
| Dec 17, 1990 | K905205 | DW 235 Ivoclar North America, Inc. | EJJ |
| Jul 13, 1990 | K902249 | LUXALLOY 50 (POWDER, TABLETS, PREDOSED CAPSULES) Degussa AG, DE | EJJ |
| Jul 13, 1990 | K902248 | LUXALLOY CAPS (PREDOSED CAPSULES) Degussa AG, DE | EJJ |
| Jul 13, 1990 | K902247 | ARTALLOY (POWDER) Degussa AG, DE | EJJ |
| Jun 1, 1990 | K901911 | VIVAALLOY HR (AMALGAM) Ivoclar North America, Inc. | EJJ |
| Apr 27, 1990 | K901256 | AMALCAP PLUS Ivoclar North America, Inc. | EJJ |
| May 9, 1989 | K890662 | PENT CAPS Jeneric/Pentron, Inc. | EJJ |
| May 5, 1989 | K890682 | OROSPHERE PLUS Jeneric/Pentron, Inc. | EJJ |
| May 2, 1989 | K890681 | OROSPHERE HCDP Jeneric/Pentron, Inc. | EJJ |
| Apr 17, 1989 | K891390 | GK ALLOY China Link, Inc. | EJJ |
| Apr 21, 1988 | K881333 | OLYMPIA ALLOY J.F. Jelenko & Co., Inc. | EJJ |
| Mar 18, 1988 | K875344 | HERAEUS' HERAGAM 48, NON GAMMA 2 DEN. AMAL. ALLOY Kulzer, Inc. | EJJ |
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