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

Denture Preformed (Partially Prefabricated Denture)

21 CFR 872.3600 / Dental
FDA source (opens on fda.gov)

EKO is the FDA product code for Denture Preformed (Partially Prefabricated Denture), a class II device type, regulated under 21 CFR 872.3600. As of , FDA records hold 4 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
EKO
Device name
Denture Preformed (Partially Prefabricated Denture)
Regulation
21 CFR 872.3600
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
4
Ingested recalls
0

Clearances, product code EKO

By decision year
4 clearances under product code EKO with a decision year between 1976 and 1990, 1976 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code EKO by decision year
YearClearances
19761
19781
19891
19901

Applicants with the most clearances

Product code EKO
Applicants holding the most 510(k) clearances under product code EKO
ApplicantClearances
Advanced Marketing Research Co.1
Dirotian Pty., Ltd.1
Flexodent Corp.1
Zinnanti Surgical Instruments, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 23 companies shown, in name order