Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Ivoclar USA, Inc. — Predicate Candidate Screening
11 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
70 daysmedian FDA review time
106 days90th percentile
11clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K012877 | HIGH GOLD PALLADIUM FREE CERAMIC SOLDER | Ivoclar USA, Inc. | 2001-11-21 | 86 | 0 |
| K981264 | ARISTON PHC | Ivoclar USA, Inc. | 1998-07-02 | 86 | 0 |
| K980986 | PROCAD | Ivoclar USA, Inc. | 1998-05-11 | 55 | 0 |
| K941849 | PROVIPONT C&B | Ivoclar USA, Inc. | 1994-08-17 | 125 | 0 |
| K923644 | DW243-64 | Ivoclar USA, Inc. | 1992-11-04 | 106 | 0 |
| K864708 | SR 3/60 NF DENTURE MATER. & SELF-CURE DENT. RESIN | Ivoclar USA, Inc. | 1987-02-25 | 85 | 0 |
| K864707 | SR-VIVODENT ANTERIOR & SR-ORTHOTYP POSTERIOR TEETH | Ivoclar USA, Inc. | 1987-02-10 | 70 | 0 |
| K864710 | ISOSIT N | Ivoclar USA, Inc. | 1987-02-10 | 70 | 0 |
| K864709 | IVOCRYL HEAT CURE & IVOCRYL QUICK DENTURE MATERIAL | Ivoclar USA, Inc. | 1987-02-10 | 70 | 0 |
| K863421 | SR-IVOLEN TRAY MATERIAL | Ivoclar USA, Inc. | 1986-11-03 | 60 | 0 |
| K844349 | SR VIVODENT PE ANTERIOR TEETH & SR ORTHOTYP RE POS | Ivoclar USA, Inc. | 1984-12-03 | 24 | 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