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

Zinc Oxide Eugenol

21 CFR 872.3275 / Dental
FDA source (opens on fda.gov)

EMB is the FDA product code for Zinc Oxide Eugenol, a class I device type, regulated under 21 CFR 872.3275. As of , FDA records hold 11 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
EMB
Device name
Zinc Oxide Eugenol
Regulation
21 CFR 872.3275
Device class
Class I
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
11
Ingested recalls
0

Clearances, product code EMB

By decision year
11 clearances under product code EMB with a decision year between 1978 and 2016, 1986 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code EMB by decision year
YearClearances
19781
19801
19821
19862
19951
20021
20081
20111
20121
20161

Applicants with the most clearances

Product code EMB
Applicants holding the most 510(k) clearances under product code EMB
ApplicantClearances
Cavex Holland B.V.1
Den-Mat Corp.1
Dentimedic1
Dentist in A Box Pty., Ltd.1
Dmg USA, Inc.1
E&D Dental Manufacturing Co.1
J. Morita USA, Inc.1
L.A.F. Industries, Inc.1
Majestic Drug Co., Inc.1
Oxy Dental Products, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 69 companies shown, in name order