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
EKNClass I

Point, Paper, Endodontic

21 CFR 872.3830 / Dental
FDA source (opens on fda.gov)

EKN is the FDA product code for Point, Paper, Endodontic, a class I device type, regulated under 21 CFR 872.3830. As of , FDA records hold 7 510(k) clearances under this code, the most recent dated , and 5 recalls.

Classification record

Product code
EKN
Device name
Point, Paper, Endodontic
Regulation
21 CFR 872.3830
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
7
Ingested recalls
5

Clearances, product code EKN

By decision year
7 clearances under product code EKN with a decision year between 1976 and 1985, 1976 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code EKN by decision year
YearClearances
19762
19781
19801
19811
19821
19851

Applicants with the most clearances

Product code EKN
Applicants holding the most 510(k) clearances under product code EKN
ApplicantClearances
United Dental Mfg., Inc.2
Adp Intl., Inc.1
Johnson & Johnson Professionals, Inc.1
Premier Dental Products Co1
Ransom & Randolph. LLC.1
Roeko1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 89 companies shown, in name order