Not currently registered with FDA under this name
Jelenko Co.
Armonk, NY, United States. Named as applicant on 12 dental 510(k) clearances between 1988 and 2001. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 121988–2001
- Markets registered in
- 595 registrations outside the US
- Establishments
- 0—
510(k) clearances per year, 1980–2026
Registered in 5 markets
Where regulators' registries name Jelenko Co. as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Applicant | Jelenko Co. | 12 clearances | 1988–2001 | Below |
| Canada | Health Canada | Registration holder | JELENKO | 84 | 2004–2004 | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | JELENKO | 6 | — | Pure Global AI |
| Brazil | ANVISA | Manufacturer | JELENKO | 4 | 2014–2017 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | JELENKO | 1 | 2011–2011 | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
510(k) clearances
Clearances on which FDA names Jelenko Co. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 8 Mar 2001 | K010416 | HERACERAM 75 | EJT Gold-Based Noble Metal Alloy |
| 10 Jan 2001 | K003603 | BIO HERADOR SG, BIO HEADER GG, HERADOR S, BIO HERADOR N, HERABOND, HERALOY G, ALBABOND, BIO MAINGOLD SG, MAINGOLD SG, HE | EJT Gold-Based Noble Metal Alloy |
| 29 Dec 1998 | K984164 | JELBOND NP | EJH Base Metal Alloy |
| 13 Dec 1996 | K964158 | JEL-40 (CODE NAME RD-0430) | EJT Gold-Based Noble Metal Alloy |
| 31 Mar 1993 | K930762 | SUPERSTAR | EJT Gold-Based Noble Metal Alloy |
| 30 Jul 1991 | K912195 | PA-396 GOLD BASED/PRECIOUS METAL ALLOYS CLIN USE | EJS Alloy Other Noble Metal |
| 30 Jul 1991 | K912194 | PA-393 GOLD BASED/PRECIOUS METAL ALLOYS CLIN USE | EJS Alloy Other Noble Metal |
| 30 Apr 1990 | K896915 | PALLADIUM BASED DENTAL ALLOY FOR PORCELAIN-METAL | EJT Gold-Based Noble Metal Alloy |
| 19 Sep 1989 | K894391 | PVS DUAL CURE VENEER BONDING KIT | KLE Resin Tooth Bonding Agent |
| 23 Aug 1989 | K893688 | HIGH NOBLE, TYPE III DENTAL CASTING ALLOY | EJT Gold-Based Noble Metal Alloy |
| 13 Feb 1989 | K885302 | GOLD/PALLADIUM BASED DENTAL ALLOY | EJT Gold-Based Noble Metal Alloy |
| 18 Mar 1988 | K874308 | JEL-62 | EJT Gold-Based Noble Metal Alloy |
Sources
FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record of the most recent filing, which can be a US agent.