Not currently registered with FDA under this name
J.F. Jelenko & Co., Inc.
Armonk, NY, United States. Named as applicant on 56 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
- 561988–2001
- Markets registered in
- 211 registrations outside the US
- Establishments
- 0—
510(k) clearances per year, 1980–2026
Registered in 2 markets
Where regulators' registries name J.F. Jelenko & Co., Inc. as the manufacturer or the registration holder of a device.
RegisteredHome: United StatesOne marker per market
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Applicant | J.F. Jelenko & Co., Inc. | 56 clearances | 1988–2001 | Below |
| South Korea | MFDS | Manufacturer | J.F. JELENKO AND COMPANYJ. F. Jelenko and Company · J.F. Jelenko & Company · +2 | 11 | 1999–2002 | 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 J.F. Jelenko & Co., Inc. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 22 Aug 2001 | K012303 | JEL-20 | EJS Alloy Other Noble Metal |
| 16 Nov 2000 | K002993 | HERACERAM | EIH Porcelain Powder |
| 19 Oct 2000 | K002645 | JEL BIOS PURE | EJT Gold-Based Noble Metal Alloy |
| 31 Aug 2000 | K002222 | RD-2104 | EJT Gold-Based Noble Metal Alloy |
| 20 Jun 2000 | K001360 | SIGNUM | EBF Resin Tooth Shade Material |
| 17 May 2000 | K001260 | ALLROUND 55 LF | EJT Gold-Based Noble Metal Alloy |
| 11 May 2000 | K001196 | JEL BIOS 90 (CODE NAME RD-2401) | EJT Gold-Based Noble Metal Alloy |
| 6 Apr 2000 | K000532 | JEL 15 | EJS Alloy Other Noble Metal |
| 6 Apr 2000 | K000213 | JELDENT BASIC LINE | ELM Teeth Plastic Denture |
| 21 Oct 1999 | K993152 | JEL BIOS 18 (CODE NAME RD- 1214) | EJT Gold-Based Noble Metal Alloy |
| 21 Oct 1999 | K993136 | JEL BIOS 10 (CODE NAME RD-1801) | EJT Gold-Based Noble Metal Alloy |
| 23 Jun 1999 | K991564 | JELTEMP | EBG Resin Temporary Crown and Bridge |
| 25 Mar 1999 | K990056 | JELDENT MULTICRYL | EBI Rebasing Repairing Relining Denture Resin |
| 17 Mar 1999 | K984587 | ALLROUND-E (CODE NAME RD 1710) | EJS Alloy Other Noble Metal |
| 13 Jan 1999 | K984140 | MAINBOND A | EJT Gold-Based Noble Metal Alloy |
| 13 Aug 1998 | K981257 | JELFINE-52 (CODE NAME RD-0901) | EJS Alloy Other Noble Metal |
| 13 Aug 1998 | K981244 | BW-1 (CODE NAME RD-0807) | EJT Gold-Based Noble Metal Alloy |
| 1 Jul 1998 | K981247 | SILCAST (CODE NAME RD-0118) | EJS Alloy Other Noble Metal |
| 24 Nov 1997 | K973881 | PROSPECTOR PLUS (CODE NAME : RD-0508) | EJT Gold-Based Noble Metal Alloy |
| 4 Jun 1997 | K971575 | BENCHMARK-IV | EJT Gold-Based Noble Metal Alloy |
| 20 May 1997 | K971574 | JELBOND-PDF | EJT Gold-Based Noble Metal Alloy |
| 20 May 1997 | K971292 | JEL-71 PDF | EJT Gold-Based Noble Metal Alloy |
| 24 Mar 1997 | K970068 | JELENKO NO.1 (CODE NAME RD-0601) | EJT Gold-Based Noble Metal Alloy |
| 26 Feb 1996 | K960403 | DIAMOND (CODE NAME PT-054) | EJT Gold-Based Noble Metal Alloy |
| 21 Feb 1996 | K960399 | TOPAZ | EJT Gold-Based Noble Metal Alloy |
| 17 Nov 1994 | K944889 | ALLROUND 4 | EJT Gold-Based Noble Metal Alloy |
| 7 Nov 1994 | K944888 | MEDALIST | EJT Gold-Based Noble Metal Alloy |
| 7 Nov 1994 | K944887 | EUREKA PLUS | EJT Gold-Based Noble Metal Alloy |
| 7 Nov 1994 | K944679 | JEL 96 | EJT Gold-Based Noble Metal Alloy |
| 1 Feb 1994 | K933623 | EUREKA | EJT Gold-Based Noble Metal Alloy |
| 8 Jul 1993 | K932130 | FREEDOM PLUS (CODE NAME MISC-LIB-013) | EJT Gold-Based Noble Metal Alloy |
| 31 Mar 1993 | K930601 | FREEDOM | EJT Gold-Based Noble Metal Alloy |
| 16 Mar 1993 | K923717 | JELENKO PORCELAIN SYSTEM PVS PROCELAIN | EIH Porcelain Powder |
| 16 Mar 1993 | K923714 | SYMPHONY | EJT Gold-Based Noble Metal Alloy |
| 11 Mar 1993 | K923817 | ULTRAGOLD | EJT Gold-Based Noble Metal Alloy |
| 5 Mar 1993 | K923722 | HN-40 | EJT Gold-Based Noble Metal Alloy |
| 5 Mar 1993 | K923721 | PROSPECTOR | EJT Gold-Based Noble Metal Alloy |
| 5 Mar 1993 | K923720 | SUNCAST | EJT Gold-Based Noble Metal Alloy |
| 5 Mar 1993 | K923719 | SUNCAST D-KF | EJT Gold-Based Noble Metal Alloy |
| 5 Mar 1993 | K923718 | HP-3 | EJT Gold-Based Noble Metal Alloy |
| 5 Mar 1993 | K923716 | JEL-0-75 | EJT Gold-Based Noble Metal Alloy |
| 5 Mar 1993 | K923715 | SUNCAST-D | EJT Gold-Based Noble Metal Alloy |
| 26 Feb 1993 | K923713 | MICROSTAR | EJT Gold-Based Noble Metal Alloy |
| 4 Dec 1992 | K922774 | COLLEGIATE | EJT Gold-Based Noble Metal Alloy |
| 5 Aug 1992 | K922451 | LEGACY-XT | EJS Alloy Other Noble Metal |
| 5 Aug 1992 | K922450 | BENCHMARK C | EJS Alloy Other Noble Metal |
| 5 Aug 1992 | K922449 | PA-400 | EJS Alloy Other Noble Metal |
| 5 Aug 1992 | K922448 | BENCHMARK I | EJS Alloy Other Noble Metal |
| 5 Aug 1992 | K922447 | BENCHMARK III | EJS Alloy Other Noble Metal |
| 5 Aug 1992 | K922446 | ACCU-STAR | EJS Alloy Other Noble Metal |
| 13 Jun 1988 | K882126 | JEL-5 GOLD BASED ALLOYS & PRECIOUS METAL ALLOYS | EJT Gold-Based Noble Metal Alloy |
| 1 Jun 1988 | K881861 | PTM-45 | EJT Gold-Based Noble Metal Alloy |
| 1 Jun 1988 | K881860 | OLYMPIA II | EJT Gold-Based Noble Metal Alloy |
| 11 May 1988 | K880348 | PALLADIUM-BASED DENTAL ALLOYS FOR PORCELAIN APPLI. | EJT Gold-Based Noble Metal Alloy |
| 21 Apr 1988 | K881333 | OLYMPIA ALLOY | EJJ Amalgam Alloy |
| 18 Apr 1988 | K881354 | RAJAH | 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.