EJJ
74 FDA 510(k) clearances · Product code
53 daysmedian time to decision
119 days90th percentile
74clearances measured
FDA profile
- Official device name
- Alloy, Amalgam
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 872.3070
- Medical specialty
- Dental
- Flags
- Third-party review eligible
- Adverse events (MAUDE)
- 2006: 6 · 2007: 49 · 2008: 9 · 2009: 5 · 2010: 22 · 2011: 8
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| SILVERFIL (K053114) | Dunia Perwira Manufacturing Sdn. Bhd. | 2005-11-15 |
| SECURALLOY, SEPTALLOY NG 50 AND SEPTALLOY NG 70 (K051010) | Septodont | 2005-05-02 |
| BESTALOY (K033434) | We Dong Myung Dental Industrial Co., Ltd. | 2003-11-12 |
| BENCO ADMIX (K032152) | Southern Dental Industries, Inc. | 2003-08-06 |
| BENCO SPHERICAL (K031658) | Southern Dental Industries, Inc. | 2003-07-29 |
| HIGH SILVER CONVENTIONAL (K020452) | Ab Ardent | 2002-05-07 |
| FUTURA TOPCAP NON GAMMA-2 (K011801) | Ab Ardent | 2001-08-16 |
| ANA 70 NON GAMMA 2 DISPERSED PHASE DENTAL ALLOY (K002811) | Nordiska Dental AB | 2000-10-31 |
| ANA 3000 SM NON GAMMA 2 MODIFIED SPHERICAL DENTAL ALLOY (K002810) | Nordiska Dental AB | 2000-10-31 |
| ANA 2000 NON GAMMA 2 EXTRA HIGH COPPER DENTAL ALLOY (K002808) | Nordiska Dental AB | 2000-10-31 |
| PARAGON (K991481) | Lancer Orthodontics, Inc. | 1999-08-11 |
| SECURALLOY (K982671) | Specialites Septodont | 1998-10-19 |
| VIVACAP HR (K982460) | Ab Ardent | 1998-08-24 |
| VIVALLOY HR (K982458) | Ab Ardent | 1998-08-24 |
| AMALCAP PLUS (K982456) | Ab Ardent | 1998-08-24 |
| CENTURY ALLOY (K974035) | Dentsply Intl. | 1997-12-17 |
| PLA-96P (K973086) | Southern Dental Industries, Inc. | 1997-10-07 |
| PLS-96P (K973088) | Southern Dental Industries, Inc. | 1997-10-03 |
| ARDENT NON GAMMA-2 70 (K964192) | Ardent Production Development | 1997-01-06 |
| ARDENT FUTURA NON GAMMA-2 (K964775) | Ardent Production Development | 1996-12-10 |
| GALLOY (K955285) | Southern Dental Industries, Inc. | 1996-01-24 |
| CUPRALLOY (K952670) | Wykle Research, Inc. | 1995-08-25 |
| TYTIN R (K951663) | Kerr Corporation (Danbury) | 1995-06-06 |
| ULTRA SPHERICAL AMALGAM ALLOY (K951865) | Goldsmith & Revere, Inc. | 1995-05-25 |
| TYTIN ADMIX (K951511) | Kerr Corporation (Danbury) | 1995-05-02 |
| AGALLOY, DISALLOY, EPSILON AND LAMBDA (K942430) | Fen Dental Mfg., Inc. | 1994-07-14 |
| SYBRALOY (K940675) | Sybron Dental Specialties, Inc. | 1994-04-29 |
| TYTIN (K935535) | Kerr Corporation (Danbury) | 1994-03-11 |
| INDIPERSE (K936113) | Indisperse Distributing, Inc. | 1994-02-10 |
| PRINCE (K933309) | Goldsmith & Revere, Inc. | 1993-10-01 |
| DISPOSABLE TURP FLUID CONTAINMENT DRAPE - STERILE (K922100) | Graham Medical Products | 1993-03-15 |
| GK DENTAL AMALGAM ALLOY (K923640) | The Patron Trading Corp. | 1993-02-12 |
| ANA 70 DISPERSED PHASE DENTAL ALLOY -- MODIFIED (K923384) | L.C. Dental | 1993-01-11 |
| AMALGAPHASE (K921538) | Saskan Amalgam Alloys, Inc. | 1992-08-10 |
| KERALLOY-D CAPS (K915654) | Wilde-USA, Inc. | 1992-03-02 |
| MIRACLE MIX CAPS GLASS IONOMER CEMENT INCAPSULES (K913175) | G-C Intl. Corp. | 1991-12-27 |
| KERALLOY NON-GAMMA 2 AMALGAM (K912992) | Wilde-USA, Inc. | 1991-11-13 |
| DW 236 (K905204) | Ivoclar North America, Inc. | 1991-03-29 |
| DW 235 (K905205) | Ivoclar North America, Inc. | 1990-12-17 |
| LUXALLOY 50 (POWDER, TABLETS, PREDOSED CAPSULES) (K902249) | Degussa AG | 1990-07-13 |
| ARTALLOY (POWDER) (K902247) | Degussa AG | 1990-07-13 |
| LUXALLOY CAPS (PREDOSED CAPSULES) (K902248) | Degussa AG | 1990-07-13 |
| VIVAALLOY HR (AMALGAM) (K901911) | Ivoclar North America, Inc. | 1990-06-01 |
| AMALCAP PLUS (K901256) | Ivoclar North America, Inc. | 1990-04-27 |
| PENT CAPS (K890662) | Jeneric/Pentron, Inc. | 1989-05-09 |
| OROSPHERE PLUS (K890682) | Jeneric/Pentron, Inc. | 1989-05-05 |
| OROSPHERE HCDP (K890681) | Jeneric/Pentron, Inc. | 1989-05-02 |
| GK ALLOY (K891390) | China Link, Inc. | 1989-04-17 |
| OLYMPIA ALLOY (K881333) | J.F. Jelenko & Co., Inc. | 1988-04-21 |
| HERAEUS' HERAGAM 48, NON GAMMA 2 DEN. AMAL. ALLOY (K875344) | Kulzer, Inc. | 1988-03-18 |
| ALLOY FOR DENTAL AMALGAM LUXALLOY NON GAMMA 2 (K870230) | Degussa Dental, Inc. | 1987-05-20 |
| LIMI ALLOY (K844653) | G-C Intl. Corp. | 1985-03-25 |
| COLTENE ORALLOY MAGICAPS (K840297) | Coltene, Inc. | 1984-03-16 |
| REX-CAPS (K823098) | Bauer, Cheng & Associates, Inc. | 1982-11-10 |
| SPHEREX E.C.T. (K822951) | Jeneric Ind. | 1982-10-26 |
| VALULINE* AMALGAM ALLOY (K821971) | Johnson & Johnson Professionals, Inc. | 1982-07-20 |
| DENTAL AMALGAM ALLOY (K821226) | Dental Alloyers Intl., Inc. | 1982-06-07 |
| GOLDSMITH & REVERE TENARY ALLOY (K821222) | Goldsmith & Revere, Inc. | 1982-05-24 |
| LUSTRALLOY (K820738) | Hoyt Laboratories | 1982-04-09 |
| DISPERSED PHASE ALLOY (K820617) | Goldsmith & Revere, Inc. | 1982-03-25 |
| A DENTAL AMALGAM ALLOY (UNNAMED (K820389) | Dentsply Intl. | 1982-03-11 |
| SYBRON/KERR CONTOUR (K820181) | Sybron Corp. | 1982-02-24 |
| ORBIC* SPHERICAL ALLOY (K812827) | Johnson & Johnson Professionals, Inc. | 1981-11-16 |
| COLTENE ORALLY (K810907) | Coltene, Inc. | 1981-04-23 |
| PERMITE DENTAL AMALGAM ALLOY (K801639) | Southern Dental Industries, Inc. | 1980-08-27 |
| VALIANT (K801690) | L.D. Caulk Co. | 1980-08-13 |
| AMALCAP-NON-GAMMA-2 (K790874) | Vivadent (Usa), Inc. | 1979-06-05 |
| EASYFIL (K790448) | General Refineries, Inc. | 1979-04-11 |
| ALLOY, AMALGAM, DISP. CAPSULE (K781242) | Lee Pharmaceuticals | 1978-08-21 |
| AMALGAM ALLOY (K780997) | Syntex Corp. | 1978-07-27 |
| LEE-ALLOY (K780967) | Lee Pharmaceuticals | 1978-06-22 |
| EASE (MODIFICATION TO) (K771403) | L.D. Caulk Co. | 1977-08-22 |
| ALLOY DISPOS-A-CAP DENTAL SCHOOL CAP (K771383) | Johnson & Johnson Professionals, Inc. | 1977-08-03 |
| DENTAL ALLOY (K760980) | Adp Intl., Inc. | 1976-11-15 |
Track EJJ automatically
Every clearance here is in the API, with alerts when new ones post.