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

Carver, Dental Amalgam, Operative

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

EKH is the FDA product code for Carver, Dental Amalgam, 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 one recall.

Classification record

Product code
EKH
Device name
Carver, Dental Amalgam, 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
1

Clearances, product code EKH

By decision year
3 clearances under product code EKH with a decision year between 1978 and 1982, 1982 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code EKH by decision year
YearClearances
19781
19822

Applicants with the most clearances

Product code EKH
Applicants holding the most 510(k) clearances under product code EKH
ApplicantClearances
Miltex, Inc.1
Pacific Dental Corp.1
Premier Dental Products Co1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 95 companies shown, in name order