FDA Product Code
FDA Product Code EJJ — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Dental
- 21 CFR Citation
- 872.3070
510(k) Clearances — 74 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K053114 | SILVERFIL | Dunia Perwira Manufacturing Sdn. Bhd. | 2005-11-15 | Traditional | PDF ↗ |
| K051010 | SECURALLOY, SEPTALLOY NG 50 AND SEPTALLOY NG 70 | Septodont | 2005-05-02 | Special | PDF ↗ |
| K033434 | BESTALOY | We Dong Myung Dental Industrial Co., Ltd. | 2003-11-12 | Traditional | PDF ↗ |
| K032152 | BENCO ADMIX | Southern Dental Industries, Inc. | 2003-08-06 | Traditional | PDF ↗ |
| K031658 | BENCO SPHERICAL | Southern Dental Industries, Inc. | 2003-07-29 | Traditional | PDF ↗ |
| K020452 | HIGH SILVER CONVENTIONAL | Ab Ardent | 2002-05-07 | Traditional | PDF ↗ |
| K011801 | FUTURA TOPCAP NON GAMMA-2 | Ab Ardent | 2001-08-16 | Traditional | PDF ↗ |
| K002810 | ANA 3000 SM NON GAMMA 2 MODIFIED SPHERICAL DENTAL ALLOY | Nordiska Dental AB | 2000-10-31 | Traditional | PDF ↗ |
| K002808 | ANA 2000 NON GAMMA 2 EXTRA HIGH COPPER DENTAL ALLOY | Nordiska Dental AB | 2000-10-31 | Traditional | PDF ↗ |
| K002811 | ANA 70 NON GAMMA 2 DISPERSED PHASE DENTAL ALLOY | Nordiska Dental AB | 2000-10-31 | Traditional | PDF ↗ |
| K991481 | PARAGON | Lancer Orthodontics, Inc. | 1999-08-11 | Traditional | PDF ↗ |
| K982671 | SECURALLOY | Specialites Septodont | 1998-10-19 | Traditional | PDF ↗ |
| K982458 | VIVALLOY HR | Ab Ardent | 1998-08-24 | Traditional | PDF ↗ |
| K982460 | VIVACAP HR | Ab Ardent | 1998-08-24 | Traditional | PDF ↗ |
| K982456 | AMALCAP PLUS | Ab Ardent | 1998-08-24 | Traditional | PDF ↗ |
| K974035 | CENTURY ALLOY | Dentsply Intl. | 1997-12-17 | Traditional | PDF ↗ |
| K973086 | PLA-96P | Southern Dental Industries, Inc. | 1997-10-07 | Traditional | PDF ↗ |
| K973088 | PLS-96P | Southern Dental Industries, Inc. | 1997-10-03 | Traditional | PDF ↗ |
| K964192 | ARDENT NON GAMMA-2 70 | Ardent Production Development | 1997-01-06 | Traditional | PDF ↗ |
| K964775 | ARDENT FUTURA NON GAMMA-2 | Ardent Production Development | 1996-12-10 | Traditional | PDF ↗ |
| K955285 | GALLOY | Southern Dental Industries, Inc. | 1996-01-24 | Traditional | PDF ↗ |
| K952670 | CUPRALLOY | Wykle Research, Inc. | 1995-08-25 | Traditional | PDF ↗ |
| K951663 | TYTIN R | Kerr Corporation (Danbury) | 1995-06-06 | Traditional | PDF ↗ |
| K951865 | ULTRA SPHERICAL AMALGAM ALLOY | Goldsmith & Revere, Inc. | 1995-05-25 | Traditional | PDF ↗ |
| K951511 | TYTIN ADMIX | Kerr Corporation (Danbury) | 1995-05-02 | Traditional | PDF ↗ |
| K942430 | AGALLOY, DISALLOY, EPSILON AND LAMBDA | Fen Dental Mfg., Inc. | 1994-07-14 | Traditional | PDF ↗ |
| K940675 | SYBRALOY | Sybron Dental Specialties, Inc. | 1994-04-29 | Traditional | PDF ↗ |
| K935535 | TYTIN | Kerr Corporation (Danbury) | 1994-03-11 | Traditional | PDF ↗ |
| K936113 | INDIPERSE | Indisperse Distributing, Inc. | 1994-02-10 | Traditional | PDF ↗ |
| K933309 | PRINCE | Goldsmith & Revere, Inc. | 1993-10-01 | Traditional | PDF ↗ |
| K922100 | DISPOSABLE TURP FLUID CONTAINMENT DRAPE - STERILE | Graham Medical Products | 1993-03-15 | Traditional | PDF ↗ |
| K923640 | GK DENTAL AMALGAM ALLOY | The Patron Trading Corp. | 1993-02-12 | Traditional | PDF ↗ |
| K923384 | ANA 70 DISPERSED PHASE DENTAL ALLOY -- MODIFIED | L.C. Dental | 1993-01-11 | Traditional | PDF ↗ |
| K921538 | AMALGAPHASE | Saskan Amalgam Alloys, Inc. | 1992-08-10 | Traditional | PDF ↗ |
| K915654 | KERALLOY-D CAPS | Wilde-USA, Inc. | 1992-03-02 | Traditional | PDF ↗ |
| K913175 | MIRACLE MIX CAPS GLASS IONOMER CEMENT INCAPSULES | G-C Intl. Corp. | 1991-12-27 | Traditional | PDF ↗ |
| K912992 | KERALLOY NON-GAMMA 2 AMALGAM | Wilde-USA, Inc. | 1991-11-13 | Traditional | PDF ↗ |
| K905204 | DW 236 | Ivoclar North America, Inc. | 1991-03-29 | Traditional | PDF ↗ |
| K905205 | DW 235 | Ivoclar North America, Inc. | 1990-12-17 | Traditional | PDF ↗ |
| K902247 | ARTALLOY (POWDER) | Degussa AG | 1990-07-13 | Traditional | PDF ↗ |
| K902248 | LUXALLOY CAPS (PREDOSED CAPSULES) | Degussa AG | 1990-07-13 | Traditional | PDF ↗ |
| K902249 | LUXALLOY 50 (POWDER, TABLETS, PREDOSED CAPSULES) | Degussa AG | 1990-07-13 | Traditional | PDF ↗ |
| K901911 | VIVAALLOY HR (AMALGAM) | Ivoclar North America, Inc. | 1990-06-01 | Traditional | PDF ↗ |
| K901256 | AMALCAP PLUS | Ivoclar North America, Inc. | 1990-04-27 | Traditional | PDF ↗ |
| K890662 | PENT CAPS | Jeneric/Pentron, Inc. | 1989-05-09 | Traditional | PDF ↗ |
| K890682 | OROSPHERE PLUS | Jeneric/Pentron, Inc. | 1989-05-05 | Traditional | PDF ↗ |
| K890681 | OROSPHERE HCDP | Jeneric/Pentron, Inc. | 1989-05-02 | Traditional | PDF ↗ |
| K891390 | GK ALLOY | China Link, Inc. | 1989-04-17 | Traditional | PDF ↗ |
| K881333 | OLYMPIA ALLOY | J.F. Jelenko & Co., Inc. | 1988-04-21 | Traditional | PDF ↗ |
| K875344 | HERAEUS' HERAGAM 48, NON GAMMA 2 DEN. AMAL. ALLOY | Kulzer, Inc. | 1988-03-18 | Traditional | PDF ↗ |
| K870230 | ALLOY FOR DENTAL AMALGAM LUXALLOY NON GAMMA 2 | Degussa Dental, Inc. | 1987-05-20 | Traditional | PDF ↗ |
| K844653 | LIMI ALLOY | G-C Intl. Corp. | 1985-03-25 | Traditional | PDF ↗ |
| K840297 | COLTENE ORALLOY MAGICAPS | Coltene, Inc. | 1984-03-16 | Traditional | PDF ↗ |
| K823098 | REX-CAPS | Bauer, Cheng & Associates, Inc. | 1982-11-10 | Traditional | PDF ↗ |
| K822951 | SPHEREX E.C.T. | Jeneric Ind. | 1982-10-26 | Traditional | PDF ↗ |
| K821971 | VALULINE* AMALGAM ALLOY | Johnson & Johnson Professionals, Inc. | 1982-07-20 | Traditional | PDF ↗ |
| K821226 | DENTAL AMALGAM ALLOY | Dental Alloyers Intl., Inc. | 1982-06-07 | Traditional | PDF ↗ |
| K821222 | GOLDSMITH & REVERE TENARY ALLOY | Goldsmith & Revere, Inc. | 1982-05-24 | Traditional | PDF ↗ |
| K820738 | LUSTRALLOY | Hoyt Laboratories | 1982-04-09 | Traditional | PDF ↗ |
| K820617 | DISPERSED PHASE ALLOY | Goldsmith & Revere, Inc. | 1982-03-25 | Traditional | PDF ↗ |
| K820389 | A DENTAL AMALGAM ALLOY (UNNAMED | Dentsply Intl. | 1982-03-11 | Traditional | PDF ↗ |
| K820181 | SYBRON/KERR CONTOUR | Sybron Corp. | 1982-02-24 | Traditional | PDF ↗ |
| K812827 | ORBIC* SPHERICAL ALLOY | Johnson & Johnson Professionals, Inc. | 1981-11-16 | Traditional | PDF ↗ |
| K810907 | COLTENE ORALLY | Coltene, Inc. | 1981-04-23 | Traditional | PDF ↗ |
| K801639 | PERMITE DENTAL AMALGAM ALLOY | Southern Dental Industries, Inc. | 1980-08-27 | Traditional | PDF ↗ |
| K801690 | VALIANT | L.D. Caulk Co. | 1980-08-13 | Traditional | PDF ↗ |
| K790874 | AMALCAP-NON-GAMMA-2 | Vivadent (Usa), Inc. | 1979-06-05 | Traditional | PDF ↗ |
| K790448 | EASYFIL | General Refineries, Inc. | 1979-04-11 | Traditional | PDF ↗ |
| K781242 | ALLOY, AMALGAM, DISP. CAPSULE | Lee Pharmaceuticals | 1978-08-21 | Traditional | PDF ↗ |
| K780997 | AMALGAM ALLOY | Syntex Corp. | 1978-07-27 | Traditional | PDF ↗ |
| K780967 | LEE-ALLOY | Lee Pharmaceuticals | 1978-06-22 | Traditional | PDF ↗ |
| K771403 | EASE (MODIFICATION TO) | L.D. Caulk Co. | 1977-08-22 | Traditional | PDF ↗ |
| K771383 | ALLOY DISPOS-A-CAP DENTAL SCHOOL CAP | Johnson & Johnson Professionals, Inc. | 1977-08-03 | Traditional | PDF ↗ |
| K760980 | DENTAL ALLOY | Adp Intl., Inc. | 1976-11-15 | Traditional | PDF ↗ |
Product code EJJ · Class II · Dental. Data: openFDA.