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

Explorer, Operative

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

EKB is the FDA product code for Explorer, Operative, a class I device type, regulated under 21 CFR 872.4565. As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and 7 recalls.

Classification record

Product code
EKB
Device name
Explorer, Operative
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
3
Ingested recalls
7

Clearances, product code EKB

By decision year
3 clearances under product code EKB with a decision year between 1982 and 1985, 1982 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code EKB by decision year
YearClearances
19821
19831
19851

Applicants with the most clearances

Product code EKB
Applicants holding the most 510(k) clearances under product code EKB
ApplicantClearances
Artiberia1
Pacific Dental Corp.1
Treace Medical, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 144 companies shown, in name order