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

Burnisher, Operative

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

EKJ is the FDA product code for Burnisher, Operative, a class I device type, regulated under 21 CFR 872.4565. As of , FDA records hold 72 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
EKJ
Device name
Burnisher, 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
72
Ingested recalls
0

Clearances, product code EKJ

By decision year
72 clearances under product code EKJ with a decision year between 1982 and 1996, 1989 the highest year at 18.
Show the numbers
510(k) clearances under FDA product code EKJ by decision year
YearClearances
19821
19871
198812
198918
199014
19916
19922
19933
199411
19952
19962

Applicants with the most clearances

Product code EKJ
Applicants holding the most 510(k) clearances under product code EKJ
ApplicantClearances
American Medical Ceramics, Inc.11
Centrix, Inc.4
Brevet Inc.3
Dentsply Intl.3
Protector, Inc.3
Tern Chien Ent. Co., Ltd.3
Wen Hao, Inc.3
Magnum Instruments, Inc.2
Pulpdent Corporation2
Zinnanti Surgical Instruments, Inc.2

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 99 companies shown, in name order