Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Jelenko Co. — Predicate Candidate Screening
12 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
64 daysmedian FDA review time
140 days90th percentile
12clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K010416 | HERACERAM 75 | Jelenko Co. | 2001-03-08 | 24 | 0 |
| K003603 | BIO HERADOR SG, BIO HEADER GG, HERADOR S, BIO HERADOR N, HER | Jelenko Co. | 2001-01-10 | 50 | 0 |
| K984164 | JELBOND NP | Jelenko Co. | 1998-12-29 | 39 | 0 |
| K964158 | JEL-40 (CODE NAME RD-0430) | Jelenko Co. | 1996-12-13 | 58 | 0 |
| K930762 | SUPERSTAR | Jelenko Co. | 1993-03-31 | 47 | 0 |
| K912195 | PA-396 GOLD BASED/PRECIOUS METAL ALLOYS CLIN USE | Jelenko Co. | 1991-07-30 | 74 | 0 |
| K912194 | PA-393 GOLD BASED/PRECIOUS METAL ALLOYS CLIN USE | Jelenko Co. | 1991-07-30 | 74 | 0 |
| K896915 | PALLADIUM BASED DENTAL ALLOY FOR PORCELAIN-METAL | Jelenko Co. | 1990-04-30 | 140 | 0 |
| K894391 | PVS DUAL CURE VENEER BONDING KIT | Jelenko Co. | 1989-09-19 | 64 | 0 |
| K893688 | HIGH NOBLE, TYPE III DENTAL CASTING ALLOY | Jelenko Co. | 1989-08-23 | 99 | 0 |
| K885302 | GOLD/PALLADIUM BASED DENTAL ALLOY | Jelenko Co. | 1989-02-13 | 48 | 0 |
| K874308 | JEL-62 | Jelenko Co. | 1988-03-18 | 150 | 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