Company · US

J.F. Jelenko & Co., Inc.

FDA 510(k) clearances and medical device recalls filed under this name, 1988 to 2001. Name variants (Inc, Corp, punctuation) are merged.

56510(k) clearances (0 in 12 months)

0recalls (0 in 12 months)

0recalls that name a 510(k)

Product codes

Code	Device	Records
EJT	Alloy, Gold-Based Noble Metal	38
EJS	Alloy, Other Noble Metal	11
EIH	Powder, Porcelain	2
EBF	Material, Tooth Shade, Resin	1
EBG	Crown And Bridge, Temporary, Resin	1
EBI	Resin, Denture, Relining, Repairing, Rebasing	1
EJJ	Alloy, Amalgam	1
ELM	Denture, Plastic, Teeth	1

Latest 510(k) clearances

Decided	510(k)	Device and applicant	Code
Aug 22, 2001	K012303	JEL-20 J.F. Jelenko & Co., Inc.	EJS
Nov 16, 2000	K002993	HERACERAM J.F. Jelenko & Co., Inc.	EIH
Oct 19, 2000	K002645	JEL BIOS PURE J.F. Jelenko & Co., Inc.	EJT
Aug 31, 2000	K002222	RD-2104 J.F. Jelenko & Co., Inc.	EJT
Jun 20, 2000	K001360	SIGNUM J.F. Jelenko & Co., Inc.	EBF
May 17, 2000	K001260	ALLROUND 55 LF J.F. Jelenko & Co., Inc.	EJT
May 11, 2000	K001196	JEL BIOS 90 (CODE NAME RD-2401) J.F. Jelenko & Co., Inc.	EJT
Apr 6, 2000	K000532	JEL 15 J.F. Jelenko & Co., Inc.	EJS
Apr 6, 2000	K000213	JELDENT BASIC LINE J.F. Jelenko & Co.	ELM
Oct 21, 1999	K993152	JEL BIOS 18 (CODE NAME RD- 1214) J.F. Jelenko & Co., Inc.	EJT
Oct 21, 1999	K993136	JEL BIOS 10 (CODE NAME RD-1801) J.F. Jelenko & Co., Inc.	EJT
Jun 23, 1999	K991564	JELTEMP J.F. Jelenko & Co., Inc.	EBG
Mar 25, 1999	K990056	JELDENT MULTICRYL J.F. Jelenko & Co., Inc.	EBI
Mar 17, 1999	K984587	ALLROUND-E (CODE NAME RD 1710) J.F. Jelenko & Co., Inc.	EJS
Jan 13, 1999	K984140	MAINBOND A J.F. Jelenko & Co., Inc.	EJT
Aug 13, 1998	K981257	JELFINE-52 (CODE NAME RD-0901) J.F. Jelenko & Co., Inc.	EJS
Aug 13, 1998	K981244	BW-1 (CODE NAME RD-0807) J.F. Jelenko & Co., Inc.	EJT
Jul 1, 1998	K981247	SILCAST (CODE NAME RD-0118) J.F. Jelenko & Co., Inc.	EJS
Nov 24, 1997	K973881	PROSPECTOR PLUS (CODE NAME : RD-0508) J.F. Jelenko & Co., Inc.	EJT
Jun 4, 1997	K971575	BENCHMARK-IV J.F. Jelenko & Co., Inc.	EJT
May 20, 1997	K971574	JELBOND-PDF J.F. Jelenko & Co., Inc.	EJT
May 20, 1997	K971292	JEL-71 PDF J.F. Jelenko & Co., Inc.	EJT
Mar 24, 1997	K970068	JELENKO NO.1 (CODE NAME RD-0601) J.F. Jelenko & Co., Inc.	EJT
Feb 26, 1996	K960403	DIAMOND (CODE NAME PT-054) J.F. Jelenko & Co., Inc.	EJT
Feb 21, 1996	K960399	TOPAZ J.F. Jelenko & Co., Inc.	EJT
Nov 17, 1994	K944889	ALLROUND 4 J.F. Jelenko & Co., Inc.	EJT
Nov 7, 1994	K944888	MEDALIST J.F. Jelenko & Co., Inc.	EJT
Nov 7, 1994	K944887	EUREKA PLUS J.F. Jelenko & Co., Inc.	EJT
Nov 7, 1994	K944679	JEL 96 J.F. Jelenko & Co., Inc.	EJT
Feb 1, 1994	K933623	EUREKA J.F. Jelenko & Co., Inc.	EJT
Jul 8, 1993	K932130	FREEDOM PLUS (CODE NAME MISC-LIB-013) J.F. Jelenko & Co., Inc.	EJT
Mar 31, 1993	K930601	FREEDOM J.F. Jelenko & Co., Inc.	EJT
Mar 16, 1993	K923717	JELENKO PORCELAIN SYSTEM PVS PROCELAIN J.F. Jelenko & Co., Inc.	EIH
Mar 16, 1993	K923714	SYMPHONY J.F. Jelenko & Co., Inc.	EJT
Mar 11, 1993	K923817	ULTRAGOLD J.F. Jelenko & Co., Inc.	EJT
Mar 5, 1993	K923722	HN-40 J.F. Jelenko & Co., Inc.	EJT
Mar 5, 1993	K923721	PROSPECTOR J.F. Jelenko & Co., Inc.	EJT
Mar 5, 1993	K923720	SUNCAST J.F. Jelenko & Co., Inc.	EJT
Mar 5, 1993	K923719	SUNCAST D-KF J.F. Jelenko & Co., Inc.	EJT
Mar 5, 1993	K923718	HP-3 J.F. Jelenko & Co., Inc.	EJT
Mar 5, 1993	K923716	JEL-0-75 J.F. Jelenko & Co., Inc.	EJT
Mar 5, 1993	K923715	SUNCAST-D J.F. Jelenko & Co., Inc.	EJT
Feb 26, 1993	K923713	MICROSTAR J.F. Jelenko & Co., Inc.	EJT
Dec 4, 1992	K922774	COLLEGIATE J.F. Jelenko & Co., Inc.	EJT
Aug 5, 1992	K922451	LEGACY-XT J.F. Jelenko & Co., Inc.	EJS
Aug 5, 1992	K922450	BENCHMARK C J.F. Jelenko & Co., Inc.	EJS
Aug 5, 1992	K922449	PA-400 J.F. Jelenko & Co., Inc.	EJS
Aug 5, 1992	K922448	BENCHMARK I J.F. Jelenko & Co., Inc.	EJS
Aug 5, 1992	K922447	BENCHMARK III J.F. Jelenko & Co., Inc.	EJS
Aug 5, 1992	K922446	ACCU-STAR J.F. Jelenko & Co., Inc.	EJS

Newest 50 of 56.

Latest recalls

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