Medical Device Manufacturer · US , Armonk , NY

Jelenko Co. - FDA 510(k) Cleared Devices

12 submissions · 12 cleared · Since 1988

Recent clearances: HERACERAM 75, BIO HERADOR SG, BIO HEADER GG, HERADOR S, BIO HERADOR N, HERABOND, HERALOY G, ALBABOND, BIO MAINGOLD SG, MAINGOLD SG, HE, JELBOND NP

View 12 510(k) Devices ↓

12

Total

12

Cleared

0

Denied

FDA 510(k) Regulatory Record - Jelenko Co. Dental ✕

12 devices

1-12 of 12

Cleared Mar 08, 2001

Cleared Jan 10, 2001

BIO HERADOR SG, BIO HEADER GG, HERADOR S, BIO HERADOR N, HERABOND, HERALOY G,...

Cleared Dec 29, 1998

Cleared Dec 13, 1996

JEL-40 (CODE NAME RD-0430)

Cleared Mar 31, 1993

Cleared Jul 30, 1991

PA-393 GOLD BASED/PRECIOUS METAL ALLOYS CLIN USE

Cleared Jul 30, 1991

PA-396 GOLD BASED/PRECIOUS METAL ALLOYS CLIN USE

Cleared Apr 30, 1990

PALLADIUM BASED DENTAL ALLOY FOR PORCELAIN-METAL

Cleared Sep 19, 1989

PVS DUAL CURE VENEER BONDING KIT

Cleared Aug 23, 1989

HIGH NOBLE, TYPE III DENTAL CASTING ALLOY

Cleared Feb 13, 1989

GOLD/PALLADIUM BASED DENTAL ALLOY

Cleared Mar 18, 1988