Atlas FDA

Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account

Argen Precious Metals, Inc. · Predicate Candidate Screening

217 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

34 daysmedian FDA review time
56 days90th percentile
217clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K965216ARGI-SATIN OR OPTI0-STARArgen Precious Metals, Inc.1997-02-27590
K961352285 SLArgen Precious Metals, Inc.1996-05-20420
K961211ARGELITE 52+Argen Precious Metals, Inc.1996-04-25280
K961285ARGEDENT 40(GOLD-PALLADIUM-SILVER ALLOY FOR PORCELAIN APPLICArgen Precious Metals, Inc.1996-04-18150
K954362ARGISTAR 74Argen Precious Metals, Inc.1995-10-12240
K954358ARGENDENT GIO 86 FRArgen Precious Metals, Inc.1995-10-07190
K954359SILFREE 80SF+Argen Precious Metals, Inc.1995-10-07190
K954360ARGESOL 600Argen Precious Metals, Inc.1995-10-07190
K954361ARGENCO 68MArgen Precious Metals, Inc.1995-10-07190
K954367ARGISTAR BIO 75PFArgen Precious Metals, Inc.1995-10-07220
K954368ARGEDENT BIO 87 PFArgen Precious Metals, Inc.1995-10-07220
K954371SUREFIRE SArgen Precious Metals, Inc.1995-10-07180
K954404AUROLITE 45Argen Precious Metals, Inc.1995-10-07170
K952403AUROLITE 80Argen Precious Metals, Inc.1995-06-21300
K952402AURIUM 68MArgen Precious Metals, Inc.1995-06-16250
K950894SUREFIRE PF+ (HIGH PALLADIUM DENTAL CASTING ALLOY FOR PORCELArgen Precious Metals, Inc.1995-03-31320
K950858AUROLITE 55Argen Precious Metals, Inc.1995-03-16170
K950772ARGELITE 61 (PALLADIUM - SILVER DENTAL CASTING ALLOY FOR PORArgen Precious Metals, Inc.1995-03-13200
K943755SOLDER AUROLITE CBArgen Precious Metals, Inc.1994-09-09380
K943757SOLDER AUROLITE REPAIRArgen Precious Metals, Inc.1994-09-09380
K943838ARGESOL #760Argen Precious Metals, Inc.1994-09-02280
K943779ARGESOL #720Argen Precious Metals, Inc.1994-08-29260
K943208ARGESOL 750PYArgen Precious Metals, Inc.1994-08-01270
K943209ARGESOL PNPArgen Precious Metals, Inc.1994-08-01270
K943210ARGESOL #1005YArgen Precious Metals, Inc.1994-08-01270
K943211ARGESOL 750YArgen Precious Metals, Inc.1994-08-01270
K943212ARGESOL #830YArgen Precious Metals, Inc.1994-08-01270
K943213ARGIPLUS LOArgen Precious Metals, Inc.1994-08-01270
K943214SOLDER #204Argen Precious Metals, Inc.1994-08-01270
K943264SOLDER #205Argen Precious Metals, Inc.1994-08-01250
K943266SOLDER #210Argen Precious Metals, Inc.1994-08-01250
K943267SOLDER #211Argen Precious Metals, Inc.1994-08-01250
K943269SOLDER #209Argen Precious Metals, Inc.1994-08-01250
K943271SOLDER #206Argen Precious Metals, Inc.1994-08-01250
K942929ARGESOL LOArgen Precious Metals, Inc.1994-07-22300
K942943ARGESOL-NOVASOLArgen Precious Metals, Inc.1994-07-22300
K942978ARGESOL #650Argen Precious Metals, Inc.1994-07-22320
K942979ARGESOL-ARGICRAFT-1Argen Precious Metals, Inc.1994-07-22320
K942980ARGESOL #615Argen Precious Metals, Inc.1994-07-22320
K942981ARGESOL #585Argen Precious Metals, Inc.1994-07-22320
K943032AURIUM Y+Argen Precious Metals, Inc.1994-07-22250
K943037ARGEDENT 41Argen Precious Metals, Inc.1994-07-22250
K943087ARGESOL 750WArgen Precious Metals, Inc.1994-07-22240
K943088ARGESOL RArgen Precious Metals, Inc.1994-07-22240
K943089ARGESOL 830WArgen Precious Metals, Inc.1994-07-22240
K942859ARGESOL-YPFArgen Precious Metals, Inc.1994-07-21340
K942928ARGESOL 500Argen Precious Metals, Inc.1994-07-21290
K942589ARGESOL PArgen Precious Metals, Inc.1994-06-22210
K942590ARGESOL WArgen Precious Metals, Inc.1994-06-22210
K942595ARGELITE PF+Argen Precious Metals, Inc.1994-06-22210

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