Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Deringer-Ney, Inc. — Predicate Candidate Screening
46 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
53 daysmedian FDA review time
82 days90th percentile
46clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K933178 | GDC 3509 | Deringer-Ney, Inc. | 1993-10-14 | 106 | 0 |
| K930481 | DENTAL CASTING ALLOY MODIFICATION-PF-4 | Deringer-Ney, Inc. | 1993-03-31 | 61 | 0 |
| K930482 | DENTAL CASTING ALLOY, MODIFICATION - PF-3 | Deringer-Ney, Inc. | 1993-03-31 | 61 | 0 |
| K925273 | GDC 3445 | Deringer-Ney, Inc. | 1992-12-21 | 63 | 0 |
| K920922 | GDC 3367 | Deringer-Ney, Inc. | 1992-05-05 | 67 | 0 |
| K920060 | DENTAL SOLDER ALLOY | Deringer-Ney, Inc. | 1992-04-02 | 87 | 0 |
| K920887 | GDC-3338, DENTAL SOLDER ALLOY | Deringer-Ney, Inc. | 1992-03-19 | 77 | 0 |
| K910065 | GDC-3200 DENTAL SOLDER | Deringer-Ney, Inc. | 1991-03-15 | 65 | 0 |
| K904695 | GDC-1501 | Deringer-Ney, Inc. | 1991-01-02 | 78 | 0 |
| K904614 | GDC-1475 | Deringer-Ney, Inc. | 1990-12-19 | 69 | 0 |
| K901532 | GDC 3084 CASTING ALLOY | Deringer-Ney, Inc. | 1990-05-02 | 30 | 0 |
| K893800 | SEQUEL (CASTING ALLOY FOR PORCELAIN-FUSED-METAL) | Deringer-Ney, Inc. | 1989-12-20 | 212 | 0 |
| K892144 | MODIFIED ULTIMA LITE | Deringer-Ney, Inc. | 1989-06-07 | 84 | 0 |
| K892907 | CASTING ALLOY FOR PORCELAIN-FUSED-TO-METAL RESTOR. | Deringer-Ney, Inc. | 1989-06-06 | 47 | 0 |
| K890569 | NEYORO 65CF | Deringer-Ney, Inc. | 1989-03-09 | 31 | 0 |
| K890568 | ULTIMA LITE | Deringer-Ney, Inc. | 1989-03-09 | 31 | 0 |
| K874821 | LUNAR CASTING ALLOY FOR PORCELAIN-FUSED-TO-METAL | Deringer-Ney, Inc. | 1988-02-08 | 76 | 0 |
| K870677 | NEY-ORO 41 | Deringer-Ney, Inc. | 1987-05-12 | 82 | 0 |
| K871288 | GDC 1830 CASTING ALLOY | Deringer-Ney, Inc. | 1987-04-15 | 15 | 0 |
| K865049 | GDC 1824 | Deringer-Ney, Inc. | 1987-03-04 | 70 | 0 |
| K860119 | GDC 1742 (A CASTING ALLOY FOR DENTAL RESTORATIONS) | Deringer-Ney, Inc. | 1986-03-17 | 63 | 0 |
| K854285 | GDC 1453 CASTING ALLOY | Deringer-Ney, Inc. | 1985-12-27 | 63 | 0 |
| K852347 | DENTAL CASTING ALLOY GDC 1686 | Deringer-Ney, Inc. | 1985-07-31 | 61 | 0 |
| K850103 | GDC-1489 A CASTING ALLOY | Deringer-Ney, Inc. | 1985-02-08 | 28 | 0 |
| K850102 | GDC-1433 A CASTING ALLOY | Deringer-Ney, Inc. | 1985-02-08 | 28 | 0 |
| K850101 | GDC-1629 A CASTING ALLOY | Deringer-Ney, Inc. | 1985-02-08 | 28 | 0 |
| K833596 | GDC 1448 DEVELOPMENT NAME | Deringer-Ney, Inc. | 1983-12-29 | 78 | 0 |
| K831280 | NEY-ORO 60 | Deringer-Ney, Inc. | 1983-06-08 | 57 | 0 |
| K820277 | GDC-1130 | Deringer-Ney, Inc. | 1982-02-24 | 22 | 0 |
| K811407 | BA-93 | Deringer-Ney, Inc. | 1981-06-16 | 28 | 0 |
| K810789 | GDC-1054 | Deringer-Ney, Inc. | 1981-04-14 | 22 | 0 |
| K801277 | GDC 934 | Deringer-Ney, Inc. | 1980-07-21 | 53 | 0 |
| K792274 | TEMPO | Deringer-Ney, Inc. | 1979-11-30 | 17 | 0 |
| K792210 | GDC 802-DEVELOPMENT NAME | Deringer-Ney, Inc. | 1979-11-20 | 18 | 0 |
| K790641 | GDC-685 | Deringer-Ney, Inc. | 1979-05-01 | 32 | 0 |
| K790290 | NEY EQUI-HINGE | Deringer-Ney, Inc. | 1979-04-10 | 61 | 0 |
| K790414 | DEVELOPMENT NO. 647 | Deringer-Ney, Inc. | 1979-04-10 | 43 | 0 |
| K790006 | GDC-591 | Deringer-Ney, Inc. | 1979-02-27 | 56 | 0 |
| K781935 | NU-GLAZE | Deringer-Ney, Inc. | 1978-12-20 | 30 | 0 |
| K781169 | IMAGE | Deringer-Ney, Inc. | 1978-08-31 | 49 | 0 |
| K770172 | PELLET, CALIBRATION | Deringer-Ney, Inc. | 1977-02-07 | 12 | 0 |
| K770159 | NEYDIUM NPFLUX (FOR SOLDERING) | Deringer-Ney, Inc. | 1977-01-31 | 7 | 0 |
| K770160 | CERAMIST BRUSH | Deringer-Ney, Inc. | 1977-01-31 | 7 | 0 |
| K770158 | HEMOSTAT | Deringer-Ney, Inc. | 1977-01-31 | 7 | 0 |
| K761102 | NEY-LITE | Deringer-Ney, Inc. | 1976-12-02 | 9 | 0 |
| K761101 | NEY VIBRATOR | Deringer-Ney, Inc. | 1976-12-02 | 9 | 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