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 |
|---|---|---|---|
| May 20, 1987 | K870230 | ALLOY FOR DENTAL AMALGAM LUXALLOY NON GAMMA 2 Degussa Dental, Inc. | EJJ |
| Mar 25, 1985 | K844653 | LIMI ALLOY G-C Intl. Corp. | EJJ |
| Mar 16, 1984 | K840297 | COLTENE ORALLOY MAGICAPS Coltene, Inc. | EJJ |
| Nov 10, 1982 | K823098 | REX-CAPS Bauer, Cheng & Associates, Inc. | EJJ |
| Oct 26, 1982 | K822951 | SPHEREX E.C.T. Jeneric Ind. | EJJ |
| Jul 20, 1982 | K821971 | VALULINE* AMALGAM ALLOY Johnson & Johnson Professionals, Inc. | EJJ |
| Jun 7, 1982 | K821226 | DENTAL AMALGAM ALLOY Dental Alloyers Intl., Inc. | EJJ |
| May 24, 1982 | K821222 | GOLDSMITH & REVERE TENARY ALLOY Goldsmith & Revere, Inc. | EJJ |
| Apr 9, 1982 | K820738 | LUSTRALLOY Hoyt Laboratories | EJJ |
| Mar 25, 1982 | K820617 | DISPERSED PHASE ALLOY Goldsmith & Revere, Inc. | EJJ |
| Mar 11, 1982 | K820389 | A DENTAL AMALGAM ALLOY (UNNAMED Dentsply Intl. | EJJ |
| Feb 24, 1982 | K820181 | SYBRON/KERR CONTOUR Sybron Corp. | EJJ |
| Nov 16, 1981 | K812827 | ORBIC* SPHERICAL ALLOY Johnson & Johnson Professionals, Inc. | EJJ |
| Apr 23, 1981 | K810907 | COLTENE ORALLY Coltene, Inc. | EJJ |
| Aug 27, 1980 | K801639 | PERMITE DENTAL AMALGAM ALLOY Southern Dental Industries, Inc. | EJJ |
| Aug 13, 1980 | K801690 | VALIANT L.D. Caulk Co. | EJJ |
| Jun 5, 1979 | K790874 | AMALCAP-NON-GAMMA-2 Vivadent (Usa), Inc. | EJJ |
| Apr 11, 1979 | K790448 | EASYFIL General Refineries, Inc. | EJJ |
| Aug 21, 1978 | K781242 | ALLOY, AMALGAM, DISP. CAPSULE Lee Pharmaceuticals | EJJ |
| Jul 27, 1978 | K780997 | AMALGAM ALLOY Syntex Corp. | EJJ |
| Jun 22, 1978 | K780967 | LEE-ALLOY Lee Pharmaceuticals | EJJ |
| Aug 22, 1977 | K771403 | EASE (MODIFICATION TO) L.D. Caulk Co. | EJJ |
| Aug 3, 1977 | K771383 | ALLOY DISPOS-A-CAP DENTAL SCHOOL CAP Johnson & Johnson Professionals, Inc. | EJJ |
| Nov 15, 1976 | K760980 | DENTAL ALLOY Adp Intl., Inc. | EJJ |
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