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

Cement, Ear, Nose And Throat

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

NEA is the FDA product code for Cement, Ear, Nose And Throat, a class II device type, regulated under 21 CFR 872.3275. As of , FDA records hold 6 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
NEA
Device name
Cement, Ear, Nose And Throat
Regulation
21 CFR 872.3275
Device class
Class II
Review panel
Dental
Submission type
510(k)
Implant
Yes
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
6
Ingested recalls
0

Clearances, product code NEA

By decision year
6 clearances under product code NEA with a decision year between 2001 and 2014, 2001 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code NEA by decision year
YearClearances
20012
20041
20061
20081
20141

Applicants with the most clearances

Product code NEA
Applicants holding the most 510(k) clearances under product code NEA
ApplicantClearances
Corinthian Medical, Ltd.1
Envoy Medical Corporation1
Ototech, Ltd.1
Ototronix, LLC1
Stryker Cmf1
Biomet Microfixation1

Companies listing this code with FDA

Companies whose registered establishments list this code