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

Frame, Rubber Dam

21 CFR 872.6300 / Dental
FDA source (opens on fda.gov)

EJE is the FDA product code for Frame, Rubber Dam, a class I device type, regulated under 21 CFR 872.6300. As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
EJE
Device name
Frame, Rubber Dam
Regulation
21 CFR 872.6300
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
3
Ingested recalls
0

Clearances, product code EJE

By decision year
3 clearances under product code EJE with a decision year between 1977 and 1978, 1978 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code EJE by decision year
YearClearances
19771
19782

Applicants with the most clearances

Product code EJE
Applicants holding the most 510(k) clearances under product code EJE
ApplicantClearances
Hygienic Dental Mfg., Co., the2
Young Dental Manufacturing Co 1, LLC.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 61 companies shown, in name order