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

Mercury

21 CFR 872.3070 / Dental
FDA source (opens on fda.gov)

ELY is the FDA product code for Mercury, a class II device type, regulated under 21 CFR 872.3070. As of , FDA records hold 4 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
ELY
Device name
Mercury
Regulation
21 CFR 872.3070
Device class
Class II
Review panel
Dental
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
4
Ingested recalls
0

Clearances, product code ELY

By decision year
4 clearances under product code ELY with a decision year between 1990 and 2010, 1990 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code ELY by decision year
YearClearances
19901
19921
19981
20101

Applicants with the most clearances

Product code ELY
Applicants holding the most 510(k) clearances under product code ELY
ApplicantClearances
Aleaciones Dentales Zeyco, S.A. de C.V.1
Degussa AG1
Dmg USA, Inc.1
National Health-Care Equipment, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code