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

Preparer, Root Canal Endodontic

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

EKQ is the FDA product code for Preparer, Root Canal Endodontic, 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
EKQ
Device name
Preparer, Root Canal 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
2
Ingested recalls
0

Clearances, product code EKQ

By decision year
2 clearances under product code EKQ with a decision year between 1980 and 1983, 1980 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code EKQ by decision year
YearClearances
19801
19831

Applicants with the most clearances

Product code EKQ
Applicants holding the most 510(k) clearances under product code EKQ
ApplicantClearances
Almore Intl., Inc.1
Syntex Dental Products, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 50 companies shown, in name order