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

Prosthesis, Condyle, Mandibular, Temporary

21 CFR 872.4770 / Dental
FDA source (opens on fda.gov)

NEI is the FDA product code for Prosthesis, Condyle, Mandibular, Temporary, a class II device type, regulated under 21 CFR 872.4770. As of , FDA records hold 7 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
NEI
Device name
Prosthesis, Condyle, Mandibular, Temporary
Regulation
21 CFR 872.4770
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
7
Ingested recalls
0

Clearances, product code NEI

By decision year
7 clearances under product code NEI with a decision year between 1999 and 2014, 2001 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code NEI by decision year
YearClearances
19991
20012
20041
20071
20081
20141

Applicants with the most clearances

Product code NEI
Applicants holding the most 510(k) clearances under product code NEI
ApplicantClearances
Synthes (USA) Products LLC3
KLS-Martin L.P.1
Osteomed1
Stryker Corp.1
Biomet Microfixation1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 14 companies shown, in name order