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

Gutta-Percha

21 CFR 872.3850 / Dental
FDA source (opens on fda.gov)

EKM is the FDA product code for Gutta-Percha, a class I device type, regulated under 21 CFR 872.3850. As of , FDA records hold 23 510(k) clearances under this code, the most recent dated , and 3 recalls.

Classification record

Product code
EKM
Device name
Gutta-Percha
Regulation
21 CFR 872.3850
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
23
Ingested recalls
3

Clearances, product code EKM

By decision year
23 clearances under product code EKM with a decision year between 1982 and 2008, 1983 the highest year at 4.
Show the numbers
510(k) clearances under FDA product code EKM by decision year
YearClearances
19821
19834
19851
19863
19881
19902
19911
19921
19932
19972
20031
20051
20061
20071
20081

Applicants with the most clearances

Product code EKM
Applicants holding the most 510(k) clearances under product code EKM
ApplicantClearances
Tulsa Dental Products LLC4
Analytic Technology2
Dr. Howard Martin, P.A.2
Endo Twinn B.V.2
Endodent, Inc.2
North Pacific Dental, Inc.2
Endo Technic Corp.1
HU-Friedy Mfg. Co. LLC1
Pentron Clinical Technologies1
Pulpdent Corporation1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 107 companies shown, in name order