Medical Device Manufacturer · US , Armonk , NY

Jelenko Co. - FDA 510(k) Cleared Devices

12 submissions · 12 cleared · Since 1988

Total

Cleared

Denied

Jelenko Co. has 12 FDA 510(k) cleared dental devices. Based in Armonk, US.

Historical record: 12 cleared submissions from 1988 to 2001.

Browse the complete list of FDA 510(k) cleared dental devices from this manufacturer. Filter by specialty or product code using the sidebar.

Jelenko Co. is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.

FDA 510(k) Regulatory Record - Jelenko Co.

12 devices

1-12 of 12

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

JEL-40 (CODE NAME RD-0430)

PA-393 GOLD BASED/PRECIOUS METAL ALLOYS CLIN USE

K912194 · EJS

Dental · 74d

Cleared Jul 30, 1991

PA-396 GOLD BASED/PRECIOUS METAL ALLOYS CLIN USE

K912195 · EJS

Dental · 74d

Cleared Apr 30, 1990

PALLADIUM BASED DENTAL ALLOY FOR PORCELAIN-METAL

K896915 · EJT

Dental · 140d

Cleared Sep 19, 1989

PVS DUAL CURE VENEER BONDING KIT

K894391 · KLE

Dental · 64d

Cleared Aug 23, 1989

HIGH NOBLE, TYPE III DENTAL CASTING ALLOY

K893688 · EJT

Dental · 99d

Cleared Feb 13, 1989

GOLD/PALLADIUM BASED DENTAL ALLOY

Jelenko Co. - FDA 510(k) Cleared Devices

FDA 510(k) Regulatory Record - Jelenko Co.

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