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

Aligner, Beam, X-Ray

21 CFR 872.1820 / Dental
FDA source (opens on fda.gov)

EHA is the FDA product code for Aligner, Beam, X-Ray, a class I device type, regulated under 21 CFR 872.1820. As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
EHA
Device name
Aligner, Beam, X-Ray
Regulation
21 CFR 872.1820
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
1
Ingested recalls
0

Clearances, product code EHA

By decision year
1 clearance under product code EHA with a decision year between 1989 and 1989, 1989 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code EHA by decision year
YearClearances
19891

Applicants with the most clearances

Product code EHA
Applicants holding the most 510(k) clearances under product code EHA
ApplicantClearances
Benn Research, Ltd.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 17 companies shown, in name order