Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of HeraeusLabelled by claude-sonnet-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under its name, each linked to the record.
As of Nov 14, 2026, FDA's public records list Jelenko Co. with 12 510(k) clearances. The most recent is a 510(k) clearance dated Mar 8, 2001: HERACERAM 75.
| Mar 8, 2001 | HERACERAM 75K010416 · EJT | 510(k) clearances |
| Jan 10, 2001 | BIO HERADOR SG, BIO HEADER GG, HERADOR S, BIO HERADOR N, HERABOND, HERALOY G, ALBABOND, BIO MAINGOLD SG, MAINGOLD SG, HEK003603 · EJT | 510(k) clearances |
| Dec 29, 1998 | JELBOND NPK984164 · EJH | 510(k) clearances |
| Dec 13, 1996 | JEL-40 (CODE NAME RD-0430)K964158 · EJT | 510(k) clearances |
| Mar 31, 1993 | SUPERSTARK930762 · EJT | 510(k) clearances |
| Jul 30, 1991 | PA-396 GOLD BASED/PRECIOUS METAL ALLOYS CLIN USEK912195 · EJS | 510(k) clearances |
| Jul 30, 1991 | PA-393 GOLD BASED/PRECIOUS METAL ALLOYS CLIN USEK912194 · EJS | 510(k) clearances |
| Apr 30, 1990 | PALLADIUM BASED DENTAL ALLOY FOR PORCELAIN-METALK896915 · EJT | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
