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

Cushion, Denture, Over The Counter

21 CFR 872.3540 / Dental
FDA source (opens on fda.gov)

EHS is the FDA product code for Cushion, Denture, Over The Counter, a class II device type, regulated under 21 CFR 872.3540. As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
EHS
Device name
Cushion, Denture, Over The Counter
Regulation
21 CFR 872.3540
Device class
Class II
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
3
Ingested recalls
0

Clearances, product code EHS

By decision year
3 clearances under product code EHS with a decision year between 1977 and 1997, 1977 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code EHS by decision year
YearClearances
19771
19821
19971

Applicants with the most clearances

Product code EHS
Applicants holding the most 510(k) clearances under product code EHS
ApplicantClearances
Combe, Inc.1
Leonard Russo Co.1
Lloyd V. Ziemendorf1

Companies listing this code with FDA

Companies whose registered establishments list this code