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

Guard, Disk

21 CFR 872.6010 / Dental
FDA source (opens on fda.gov)

EEJ is the FDA product code for Guard, Disk, a class I device type, regulated under 21 CFR 872.6010. As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
EEJ
Device name
Guard, Disk
Regulation
21 CFR 872.6010
Device class
Class I
Review panel
Dental
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
Yes
Third party review eligible
No
Ingested clearances
1
Ingested recalls
0

Clearances, product code EEJ

By decision year
1 clearance under product code EEJ with a decision year between 1986 and 1986, 1986 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code EEJ by decision year
YearClearances
19861

Applicants with the most clearances

Product code EEJ
Applicants holding the most 510(k) clearances under product code EEJ
ApplicantClearances
Nortex USA, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 13 companies shown, in name order