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

Cup, Prophylaxis

21 CFR 872.6290 / Dental
FDA source (opens on fda.gov)

EHK is the FDA product code for Cup, Prophylaxis, a class I device type, regulated under 21 CFR 872.6290. As of , FDA records hold 8 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
EHK
Device name
Cup, Prophylaxis
Regulation
21 CFR 872.6290
Device class
Class I
Review panel
Dental
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
Yes
Third party review eligible
No
Ingested clearances
8
Ingested recalls
1

Clearances, product code EHK

By decision year
8 clearances under product code EHK with a decision year between 1977 and 1995, 1995 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code EHK by decision year
YearClearances
19771
19781
19791
19811
19861
19901
19952

Applicants with the most clearances

Product code EHK
Applicants holding the most 510(k) clearances under product code EHK
ApplicantClearances
Dental Control Products1
Dentsply Intl.1
Mission White Dental, Inc.1
Preventive Technologies, Inc.1
Ransom & Randolph. LLC.1
Rolence Enterprise Co., Ltd.1
Teledyne Densco1
Young Dental Manufacturing Co 1, LLC.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 122 companies shown, in name order