510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
EKAClass I

File, Margin Finishing, Operative

21 CFR 872.4565 / Dental
FDA source (opens on fda.gov)

EKA is the FDA product code for File, Margin Finishing, Operative, a class I device type, regulated under 21 CFR 872.4565. As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
EKA
Device name
File, Margin Finishing, Operative
Regulation
21 CFR 872.4565
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
2
Ingested recalls
0

Clearances, product code EKA

By decision year
2 clearances under product code EKA with a decision year between 1982 and 1983, 1982 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code EKA by decision year
YearClearances
19821
19831

Applicants with the most clearances

Product code EKA
Applicants holding the most 510(k) clearances under product code EKA
ApplicantClearances
Shizai Corp.1
U.S. Shizai Corp.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 18 companies shown, in name order