510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K003603Substantially Equivalent

Bio Herador Sg, Bio Header Gg, Herador S, Bio Herador N, Herabond, Heraloy G, Albabond, Bio Maingold Sg, Maingold Sg, He

Jelenko Co., Armonk NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K003603 is the FDA 510(k) clearance record for BIO HERADOR SG, BIO HEADER GG, HERADOR S, BIO HERADOR N, HERABOND, HERALOY G, ALBABOND, BIO MAINGOLD SG, MAINGOLD SG, HE, a class II device, cleared for Jelenko Co. on under FDA product code EJT (Alloy, Gold-Based Noble Metal). FDA records list 12 510(k) clearances for Jelenko Co., from to . As of , FDA records show no recalls naming K003603.

Clearance record

Decision date
Received
(50 days to decision)
Product code
EJT Alloy, Gold-Based Noble Metal
Regulation
21 CFR 872.3060
Device class
Class II
Review panel
Dental
Applicant
Jelenko Co. 99 Business Park Dr., Armonk NY
510(k) summary
Statement
Third party review
No

Clearances, product code EJT

Trailing 12 months

FDA records hold no clearances under product code EJT in the trailing twelve months.

FDA records show no clearances under product code EJT in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code EJT, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260