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

Spreader, Pulp Canal Filling Material, Endodontic

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

EKK is the FDA product code for Spreader, Pulp Canal Filling Material, Endodontic, a class I device type, regulated under 21 CFR 872.4565. As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
EKK
Device name
Spreader, Pulp Canal Filling Material, Endodontic
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
1
Ingested recalls
0

Clearances, product code EKK

By decision year
1 clearance under product code EKK with a decision year between 1985 and 1985, 1985 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code EKK by decision year
YearClearances
19851

Applicants with the most clearances

Product code EKK
Applicants holding the most 510(k) clearances under product code EKK
ApplicantClearances
Sturgeon Engineering Co.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 90 companies shown, in name order