Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
EJJ · Predicate Candidate Screening
74 FDA 510(k) clearances under this product code; the 50 most recent screened below.
53 daysmedian FDA review time
119 days90th percentile
74clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K053114 | SILVERFIL | Dunia Perwira Manufacturing Sdn. Bhd. | 2005-11-15 | 8 | 0 |
| K051010 | SECURALLOY, SEPTALLOY NG 50 AND SEPTALLOY NG 70 | Septodont | 2005-05-02 | 11 | 0 |
| K033434 | BESTALOY | We Dong Myung Dental Industrial Co., Ltd. | 2003-11-12 | 15 | 0 |
| K032152 | BENCO ADMIX | Southern Dental Industries, Inc. | 2003-08-06 | 70 | 0 |
| K031658 | BENCO SPHERICAL | Southern Dental Industries, Inc. | 2003-07-29 | 62 | 0 |
| K020452 | HIGH SILVER CONVENTIONAL | Ab Ardent | 2002-05-07 | 85 | 0 |
| K011801 | FUTURA TOPCAP NON GAMMA-2 | Ab Ardent | 2001-08-16 | 69 | 0 |
| K002811 | ANA 70 NON GAMMA 2 DISPERSED PHASE DENTAL ALLOY | Nordiska Dental AB | 2000-10-31 | 53 | 0 |
| K002810 | ANA 3000 SM NON GAMMA 2 MODIFIED SPHERICAL DENTAL ALLOY | Nordiska Dental AB | 2000-10-31 | 53 | 0 |
| K002808 | ANA 2000 NON GAMMA 2 EXTRA HIGH COPPER DENTAL ALLOY | Nordiska Dental AB | 2000-10-31 | 53 | 0 |
| K991481 | PARAGON | Lancer Orthodontics, Inc. | 1999-08-11 | 105 | 0 |
| K982671 | SECURALLOY | Specialites Septodont | 1998-10-19 | 80 | 0 |
| K982460 | VIVACAP HR | Ab Ardent | 1998-08-24 | 40 | 0 |
| K982458 | VIVALLOY HR | Ab Ardent | 1998-08-24 | 40 | 0 |
| K982456 | AMALCAP PLUS | Ab Ardent | 1998-08-24 | 40 | 0 |
| K974035 | CENTURY ALLOY | Dentsply Intl. | 1997-12-17 | 54 | 0 |
| K973086 | PLA-96P | Southern Dental Industries, Inc. | 1997-10-07 | 50 | 0 |
| K973088 | PLS-96P | Southern Dental Industries, Inc. | 1997-10-03 | 46 | 0 |
| K964192 | ARDENT NON GAMMA-2 70 | Ardent Production Development | 1997-01-06 | 81 | 0 |
| K964775 | ARDENT FUTURA NON GAMMA-2 | Ardent Production Development | 1996-12-10 | 54 | 0 |
| K955285 | GALLOY | Southern Dental Industries, Inc. | 1996-01-24 | 68 | 0 |
| K952670 | CUPRALLOY | Wykle Research, Inc. | 1995-08-25 | 74 | 0 |
| K951663 | TYTIN R | Kerr Corporation (Danbury) | 1995-06-06 | 57 | 1 |
| K951865 | ULTRA SPHERICAL AMALGAM ALLOY | Goldsmith & Revere, Inc. | 1995-05-25 | 34 | 0 |
| K951511 | TYTIN ADMIX | Kerr Corporation (Danbury) | 1995-05-02 | 29 | 0 |
| K942430 | AGALLOY, DISALLOY, EPSILON AND LAMBDA | Fen Dental Mfg., Inc. | 1994-07-14 | 55 | 0 |
| K940675 | SYBRALOY | Sybron Dental Specialties, Inc. | 1994-04-29 | 72 | 0 |
| K935535 | TYTIN | Kerr Corporation (Danbury) | 1994-03-11 | 115 | 0 |
| K936113 | INDIPERSE | Indisperse Distributing, Inc. | 1994-02-10 | 50 | 0 |
| K933309 | PRINCE | Goldsmith & Revere, Inc. | 1993-10-01 | 86 | 0 |
| K922100 | DISPOSABLE TURP FLUID CONTAINMENT DRAPE - STERILE | Graham Medical Products | 1993-03-15 | 315 | 0 |
| K923640 | GK DENTAL AMALGAM ALLOY | The Patron Trading Corp. | 1993-02-12 | 206 | 0 |
| K923384 | ANA 70 DISPERSED PHASE DENTAL ALLOY -- MODIFIED | L.C. Dental | 1993-01-11 | 228 | 0 |
| K921538 | AMALGAPHASE | Saskan Amalgam Alloys, Inc. | 1992-08-10 | 132 | 0 |
| K915654 | KERALLOY-D CAPS | Wilde-USA, Inc. | 1992-03-02 | 75 | 0 |
| K913175 | MIRACLE MIX CAPS GLASS IONOMER CEMENT INCAPSULES | G-C Intl. Corp. | 1991-12-27 | 163 | 0 |
| K912992 | KERALLOY NON-GAMMA 2 AMALGAM | Wilde-USA, Inc. | 1991-11-13 | 128 | 0 |
| K905204 | DW 236 | Ivoclar North America, Inc. | 1991-03-29 | 129 | 0 |
| K905205 | DW 235 | Ivoclar North America, Inc. | 1990-12-17 | 27 | 0 |
| K902249 | LUXALLOY 50 (POWDER, TABLETS, PREDOSED CAPSULES) | Degussa AG | 1990-07-13 | 56 | 0 |
| K902247 | ARTALLOY (POWDER) | Degussa AG | 1990-07-13 | 56 | 0 |
| K902248 | LUXALLOY CAPS (PREDOSED CAPSULES) | Degussa AG | 1990-07-13 | 56 | 0 |
| K901911 | VIVAALLOY HR (AMALGAM) | Ivoclar North America, Inc. | 1990-06-01 | 36 | 0 |
| K901256 | AMALCAP PLUS | Ivoclar North America, Inc. | 1990-04-27 | 43 | 0 |
| K890662 | PENT CAPS | Jeneric/Pentron, Inc. | 1989-05-09 | 89 | 0 |
| K890682 | OROSPHERE PLUS | Jeneric/Pentron, Inc. | 1989-05-05 | 85 | 0 |
| K890681 | OROSPHERE HCDP | Jeneric/Pentron, Inc. | 1989-05-02 | 82 | 0 |
| K891390 | GK ALLOY | China Link, Inc. | 1989-04-17 | 34 | 0 |
| K881333 | OLYMPIA ALLOY | J.F. Jelenko & Co., Inc. | 1988-04-21 | 23 | 0 |
| K875344 | HERAEUS' HERAGAM 48, NON GAMMA 2 DEN. AMAL. ALLOY | Kulzer, Inc. | 1988-03-18 | 79 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda