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

Alloy, Other Noble Metal

21 CFR 872.3060 / Dental
FDA source (opens on fda.gov)

EJS is the FDA product code for Alloy, Other Noble Metal, a class II device type, regulated under 21 CFR 872.3060. As of , FDA records hold 194 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
EJS
Device name
Alloy, Other Noble Metal
Regulation
21 CFR 872.3060
Device class
Class II
Review panel
Dental
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
194
Ingested recalls
0

Clearances, product code EJS

By decision year
194 clearances under product code EJS with a decision year between 1976 and 2004, 1991 the highest year at 34.
Show the numbers
510(k) clearances under FDA product code EJS by decision year
YearClearances
19762
19772
19797
19804
19814
198221
198310
19844
19858
19867
19872
19886
19891
19906
199134
199218
19938
19943
19967
19977
19987
19998
20003
20014
20029
20042

Applicants with the most clearances

Product code EJS
Applicants holding the most 510(k) clearances under product code EJS
ApplicantClearances
Metalor Dental USA Corp.31
Deringer-Ney, Inc.14
Ivoclar North America, Inc.12
J.F. Jelenko & Co., Inc.11
Degussa Dental, Inc.10
Howmedica Corp.10
Jeneric/Pentron, Inc.10
Argen Precious Metals, Inc.9
J. Aderer, Inc.9
Williams Gold Refining Co., Inc.9

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 41 companies shown, in name order