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Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Leach and Dillon Co., Inc. · Predicate Candidate Screening

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

132 daysmedian FDA review time
190 days90th percentile
31clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K903538WIRON 99 DENTAL CASTING ALLOYLeach and Dillon Co., Inc.1991-03-152200
K903537250 SL DENTAL CASTING ALLOYLeach and Dillon Co., Inc.1990-10-24780
K895059HIGH FUSING YELLOW CERAMIC SOLDERLeach and Dillon Co., Inc.1990-10-054230
K895058HIGH FUSING WHITE CERAMIC SOLDERLeach and Dillon Co., Inc.1990-10-054230
K903484SELECT 20, DENTAL ALLOYLeach and Dillon Co., Inc.1990-09-14450
K902373200 SILHOUETTE LINE (SL) CERAMIC SOLDERLeach and Dillon Co., Inc.1990-06-28300
K902372SILVER-FREE CERAMIC SOLDER (SFCS)Leach and Dillon Co., Inc.1990-06-28300
K895888SILHOUETTE PORCELAINLeach and Dillon Co., Inc.1990-04-101870
K895889SHAKE N' SPRAY (W/SILHOUETTE PORCELAIN)Leach and Dillon Co., Inc.1990-04-041810
K895066MONOGRAM IVLeach and Dillon Co., Inc.1990-02-141900
K896501TECH STAR DENTAL CASTING ALLOYS (NON-PRECIOUS)Leach and Dillon Co., Inc.1990-02-09870
K895069SELECT 40Leach and Dillon Co., Inc.1989-12-191330
K895067SELECT 60Leach and Dillon Co., Inc.1989-12-191330
K895063450 SL (SILHOUETTE LINE) DENTAL CASTING ALLOYSLeach and Dillon Co., Inc.1989-12-191330
K895056LOW FUSING WHITE GOLDLeach and Dillon Co., Inc.1989-12-191330
K895070SELECT WHITELeach and Dillon Co., Inc.1989-12-191330
K895054.650 FINE GOLD SOLDERLeach and Dillon Co., Inc.1989-12-191330
K895060750 SL (SILHOUETTE LINE) DENTAL CASTING ALLOYSLeach and Dillon Co., Inc.1989-12-191330
K895049200 SL (SILHOUETTE LINE) DENTAL CASTING ALLOYSLeach and Dillon Co., Inc.1989-12-181320
K895055.730 FINE GOLD SOLDERLeach and Dillon Co., Inc.1989-12-181320
K895068SELECT 50Leach and Dillon Co., Inc.1989-12-181320
K895050100 SL (SILHOUETTE LINE) DENTAL CASTING ALLOYSLeach and Dillon Co., Inc.1989-12-181320
K895064MONOGRAM IILeach and Dillon Co., Inc.1989-12-181320
K895061700 SL (SILHOUETTE LINE) DENTAL CASTING ALLOYSLeach and Dillon Co., Inc.1989-12-181320
K895057HIGH FUSING WHITE GOLDLeach and Dillon Co., Inc.1989-12-181320
K895052.585 FINE GOLD SOLDERLeach and Dillon Co., Inc.1989-12-181320
K895053.615 FINE GOLD SOLDERLeach and Dillon Co., Inc.1989-12-181320
K895065MONOGRAM IIILeach and Dillon Co., Inc.1989-12-181320
K895062500 SL (SILHOUETTE LINE) DENTAL CASTING ALLOYSLeach and Dillon Co., Inc.1989-12-181320
K895051MONOGRAM ILeach and Dillon Co., Inc.1989-12-181320
K895048300 SL (SILHOUETTE LINE) DENTAL CASTING ALLOYSLeach and Dillon Co., Inc.1989-12-181320

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