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

Point, Silver, Endodontic

21 CFR 872.3840 / Dental
FDA source (opens on fda.gov)

EKL is the FDA product code for Point, Silver, Endodontic, a class I device type, regulated under 21 CFR 872.3840. As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
EKL
Device name
Point, Silver, Endodontic
Regulation
21 CFR 872.3840
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
3
Ingested recalls
0

Clearances, product code EKL

By decision year
3 clearances under product code EKL with a decision year between 1982 and 1999, 1982 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code EKL by decision year
YearClearances
19821
19961
19991

Applicants with the most clearances

Product code EKL
Applicants holding the most 510(k) clearances under product code EKL
ApplicantClearances
Kelleher Corp.1
Pacific Implant, Inc.1
Pulpdent Corporation1

Companies listing this code with FDA

Companies whose registered establishments list this code