Jelenko Co.
Armonk, NY, US
Jelenko Co. appears in FDA device records in Armonk, NY. FDA records list 12 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 12
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 12 510(k) clearances for Jelenko Co. between 1988 and 2001. The busiest year on record is 1989, with 3. The most recent is 2001, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1988 | 1 |
| 1989 | 3 |
| 1990 | 1 |
| 1991 | 2 |
| 1993 | 1 |
| 1996 | 1 |
| 1998 | 1 |
| 2001 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K010416 | HERACERAM 75 | EJT | Substantially Equivalent | |
| K003603 | BIO HERADOR SG, BIO HEADER GG, HERADOR S, BIO HERADOR N, HERABOND, HERALOY G, ALBABOND, BIO MAINGOLD SG, MAINGOLD SG, HE | EJT | Substantially Equivalent | |
| K984164 | JELBOND NP | EJH | Substantially Equivalent | |
| K964158 | JEL-40 (CODE NAME RD-0430) | EJT | Substantially Equivalent | |
| K930762 | SUPERSTAR | EJT | Substantially Equivalent | |
| K912195 | PA-396 GOLD BASED/PRECIOUS METAL ALLOYS CLIN USE | EJS | Substantially Equivalent | |
| K912194 | PA-393 GOLD BASED/PRECIOUS METAL ALLOYS CLIN USE | EJS | Substantially Equivalent | |
| K896915 | PALLADIUM BASED DENTAL ALLOY FOR PORCELAIN-METAL | EJT | Substantially Equivalent | |
| K894391 | PVS DUAL CURE VENEER BONDING KIT | KLE | Substantially Equivalent | |
| K893688 | HIGH NOBLE, TYPE III DENTAL CASTING ALLOY | EJT | Substantially Equivalent | |
| K885302 | GOLD/PALLADIUM BASED DENTAL ALLOY | EJT | Substantially Equivalent | |
| K874308 | JEL-62 | EJT | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain