Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

55 results for "J.F. Jelenko & Co., Inc."
1–24 of 55
Search insights Median review: 58d Cleared: 100% Top manufacturer: J.F. Jelenko & Co., Inc. Lead specialty: Dental
Cleared Aug 22, 2001
JEL-20
K012303 · EJS
J.F. Jelenko & Co., Inc.
Dental · 33d
Cleared Nov 16, 2000
HERACERAM
K002993 · EIH
J.F. Jelenko & Co., Inc.
Dental · 52d
Cleared Oct 19, 2000
JEL BIOS PURE
K002645 · EJT
J.F. Jelenko & Co., Inc.
Dental · 56d
Cleared Aug 31, 2000
RD-2104
K002222 · EJT
J.F. Jelenko & Co., Inc.
Dental · 38d
Cleared Jun 20, 2000
SIGNUM
K001360 · EBF
J.F. Jelenko & Co., Inc.
Dental · 53d
Cleared May 17, 2000
ALLROUND 55 LF
K001260 · EJT
J.F. Jelenko & Co., Inc.
Dental · 28d
Cleared May 11, 2000
JEL BIOS 90 (CODE NAME RD-2401)
K001196 · EJT
J.F. Jelenko & Co., Inc.
Dental · 29d
Cleared Apr 06, 2000
JEL 15
K000532 · EJS
J.F. Jelenko & Co., Inc.
Dental · 49d
Cleared Oct 21, 1999
JEL BIOS 18 (CODE NAME RD- 1214)
K993152 · EJT
J.F. Jelenko & Co., Inc.
Dental · 30d
Cleared Oct 21, 1999
JEL BIOS 10 (CODE NAME RD-1801)
K993136 · EJT
J.F. Jelenko & Co., Inc.
Dental · 31d
Cleared Jun 23, 1999
JELTEMP
K991564 · EBG
J.F. Jelenko & Co., Inc.
Dental · 49d
Cleared Mar 25, 1999
JELDENT MULTICRYL
K990056 · EBI
J.F. Jelenko & Co., Inc.
Dental · 77d
Cleared Mar 17, 1999
ALLROUND-E (CODE NAME RD 1710)
K984587 · EJS
J.F. Jelenko & Co., Inc.
Dental · 83d
Cleared Jan 13, 1999
MAINBOND A
K984140 · EJT
J.F. Jelenko & Co., Inc.
Dental · 56d
Cleared Aug 13, 1998
JELFINE-52 (CODE NAME RD-0901)
K981257 · EJS
J.F. Jelenko & Co., Inc.
Dental · 129d
Cleared Aug 13, 1998
BW-1 (CODE NAME RD-0807)
K981244 · EJT
J.F. Jelenko & Co., Inc.
Dental · 129d
Cleared Jul 01, 1998
SILCAST (CODE NAME RD-0118)
K981247 · EJS
J.F. Jelenko & Co., Inc.
Dental · 86d
Cleared Nov 24, 1997
PROSPECTOR PLUS (CODE NAME : RD-0508)
K973881 · EJT
J.F. Jelenko & Co., Inc.
Dental · 41d
Cleared Jun 04, 1997
BENCHMARK-IV
K971575 · EJT
J.F. Jelenko & Co., Inc.
Dental · 58d
Cleared May 20, 1997
JELBOND-PDF
K971574 · EJT
J.F. Jelenko & Co., Inc.
Dental · 43d
Cleared May 20, 1997
JEL-71 PDF
K971292 · EJT
J.F. Jelenko & Co., Inc.
Dental · 43d
Cleared Mar 24, 1997
JELENKO NO.1 (CODE NAME RD-0601)
K970068 · EJT
J.F. Jelenko & Co., Inc.
Dental · 75d
Cleared Feb 26, 1996
DIAMOND (CODE NAME PT-054)
K960403 · EJT
J.F. Jelenko & Co., Inc.
Dental · 28d
Cleared Feb 21, 1996
TOPAZ
K960399 · EJT
J.F. Jelenko & Co., Inc.
Dental · 23d