Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
EJS — Predicate Candidate Screening
194 FDA 510(k) clearances under this product code; the 50 most recent screened below.
53 daysmedian FDA review time
90 days90th percentile
194clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K041433 | BRIGHT GOLD XH | Ivoclar Vivadent, Inc. | 2004-08-19 | 83 | 0 |
| K040436 | SIMIDUR SUPERIOR | Wieland Dental + Technik GmbH & Co. KG | 2004-03-05 | 15 | 0 |
| K022252 | STERNGOLD 1, MODEL 1127781 | Sterngold | 2002-09-19 | 69 | 0 |
| K022469 | ECO E4 | Wieland Dental + Technik GmbH & Co. KG | 2002-09-18 | 54 | 0 |
| K021367 | STERNGOLD 66, MODEL #1180230 | Sterngold | 2002-05-16 | 16 | 0 |
| K020195 | SIMIDUR S1S | Wieland Dental + Technik GmbH & Co. KG | 2002-03-15 | 52 | 0 |
| K020192 | SIMIDUR S2 | Wieland Dental + Technik GmbH & Co. KG | 2002-03-15 | 52 | 0 |
| K020194 | SIMIDUR KF PLUS | Wieland Dental + Technik GmbH & Co. KG | 2002-03-15 | 52 | 0 |
| K014042 | D.SIGN 84 | Ivoclar Vivadent, Inc. | 2002-02-22 | 77 | 0 |
| K013809 | D.SIGN 59 | Ivoclar Vivadent, Inc. | 2002-02-07 | 84 | 0 |
| K014082 | D.SIGN 53, MODEL NA1012204 | Ivoclar Vivadent, Inc. | 2002-01-30 | 50 | 0 |
| K012841 | DUO PAL 6, ORDER-NO.: 2154 | Wieland Edelmetalle GmbH & Co. | 2001-11-20 | 89 | 0 |
| K012828 | PORTA SMK 82, MODEL 2032 | Wieland Edelmetalle GmbH & Co. | 2001-11-01 | 70 | 0 |
| K012840 | EURO 45, ORDER-NO.: 2064 | Wieland Edelmetalle GmbH & Co. | 2001-10-23 | 61 | 0 |
| K012303 | JEL-20 | J.F. Jelenko & Co., Inc. | 2001-08-22 | 33 | 0 |
| K003632 | DW 273 #1 | Ivoclar North America, Inc. | 2000-12-20 | 26 | 0 |
| K001469 | R&D PROJECT DW269#25 | Ivoclar North America, Inc. | 2000-07-05 | 56 | 0 |
| K000532 | JEL 15 | J.F. Jelenko & Co., Inc. | 2000-04-06 | 49 | 0 |
| K993475 | AUROFLUID M, ALLOY NO. 5315 | Metalor Dental USA Corp. | 1999-12-09 | 56 | 0 |
| K993506 | PAGALINOR 4 , ALLOY NO. 5440 | Metalor Dental USA Corp. | 1999-12-08 | 54 | 0 |
| K993505 | V-DELTA SPECIAL, ALLOY NO. 5154 | Metalor Dental USA Corp. | 1999-12-08 | 54 | 0 |
| K993474 | DELTAPAL, ALLOY NO. 5161 | Metalor Dental USA Corp. | 1999-12-02 | 49 | 0 |
| K984587 | ALLROUND-E (CODE NAME RD 1710) | J.F. Jelenko & Co., Inc. | 1999-03-17 | 83 | 0 |
| K990077 | D-SIGN III (R&D PROJECT DW264#7) | Ivoclar North America, Inc. | 1999-02-12 | 32 | 0 |
| K990078 | D-SIGN IV (R&D PROJECT DW265#37) | Ivoclar North America, Inc. | 1999-02-12 | 32 | 0 |
| K984451 | D-SIGN I (R&D PROJECT DW263 #24) | Ivoclar North America, Inc. | 1999-01-19 | 35 | 0 |
| K983081 | BEGOPAL 300 | Bego Bremer Goldschlaegerei Wilh. Herbst GmbH & CO | 1998-10-28 | 56 | 0 |
| K983078 | BEGOPAL | Bego U.S.A. | 1998-10-23 | 51 | 0 |
| K981257 | JELFINE-52 (CODE NAME RD-0901) | J.F. Jelenko & Co., Inc. | 1998-08-13 | 129 | 0 |
| K981247 | SILCAST (CODE NAME RD-0118) | J.F. Jelenko & Co., Inc. | 1998-07-01 | 86 | 0 |
| K981002 | ORION WX DENTAL ALLOY | European Dental Imports, Inc. | 1998-05-18 | 61 | 0 |
| K981001 | ORION VESTA DENTAL ALLOY | European Dental Imports, Inc. | 1998-05-18 | 61 | 0 |
| K980661 | CERA E DENTAL ALLOY | European Dental Imports, Inc. | 1998-05-01 | 70 | 0 |
| K972945 | AURENORM 68 | Aurex Precious Metal Industries (Pty)Ltd | 1997-11-26 | 159 | 0 |
| K973288 | STABILOR HN | Degussa Corp. | 1997-11-19 | 78 | 0 |
| K972533 | VERA SOLDER | Aalba Dent, Inc. | 1997-09-05 | 60 | 0 |
| K972534 | ALFALLOY | Aalba Dent, Inc. | 1997-09-05 | 60 | 0 |
| K972683 | V-DELTA 450 | Metalor Dental USA Corp. | 1997-08-18 | 32 | 0 |
| K970045 | SOLARO 33 | Metalor Dental USA Corp. | 1997-03-05 | 58 | 0 |
| K970044 | AUROFLUID 22 | Metalor Dental USA Corp. | 1997-03-05 | 58 | 0 |
| K964707 | SOLDER 585 | Gateway Alloys, Inc. | 1996-12-16 | 21 | 0 |
| K964713 | SOLDER GPW | Gateway Alloys, Inc. | 1996-12-16 | 21 | 0 |
| K964706 | SOLDER 650 | Gateway Alloys, Inc. | 1996-12-16 | 21 | 0 |
| K964705 | SOLDER GPY | Gateway Alloys, Inc. | 1996-12-16 | 21 | 0 |
| K962324 | STERNGOLD U-CPF METAL ALLOY (1067800) | Sterngold/Implamed | 1996-07-24 | 37 | 0 |
| K962304 | STERNGOLD BIO-4 | Sterngold/Implamed | 1996-07-23 | 36 | 0 |
| K962301 | STERNGOLD G-HARD METAL ALLOY | The Stern Metals Co., Inc. | 1996-07-18 | 31 | 0 |
| K941625 | DW234 #29 | Rms Div. | 1994-06-22 | 79 | 0 |
| K934757 | CU-FREE & LTA | Jeneric/Pentron, Inc. | 1994-02-04 | 123 | 0 |
| K935388 | CERAPALL 4CF | Metalor | 1994-01-06 | 58 | 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