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

Condenser, Amalgam And Foil, Operative

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

EKG is the FDA product code for Condenser, Amalgam And Foil, 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 no recalls.

Classification record

Product code
EKG
Device name
Condenser, Amalgam And Foil, 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
0

Clearances, product code EKG

By decision year
3 clearances under product code EKG with a decision year between 1982 and 1987, 1982 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code EKG by decision year
YearClearances
19821
19841
19871

Applicants with the most clearances

Product code EKG
Applicants holding the most 510(k) clearances under product code EKG
ApplicantClearances
Austenal Dental, Inc.1
Miltex, Inc.1
Shofu Dental Corp.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 55 companies shown, in name order