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

Remover, Crown

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

EIS is the FDA product code for Remover, Crown, a class I device type, regulated under 21 CFR 872.4565. As of , FDA records hold 19 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
EIS
Device name
Remover, Crown
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
19
Ingested recalls
0

Clearances, product code EIS

By decision year
19 clearances under product code EIS with a decision year between 1983 and 1999, 1983 the highest year at 12.
Show the numbers
510(k) clearances under FDA product code EIS by decision year
YearClearances
198312
19843
19862
19951
19991

Applicants with the most clearances

Product code EIS
Applicants holding the most 510(k) clearances under product code EIS
ApplicantClearances
Genesis Industries, Inc.13
Dentco, Inc.1
Fran Hazelton Co.1
Higa Manufacturing, Ltd.1
J. Morita USA, Inc.1
Jeneric Ind.1
Pacific Union Dental, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 124 companies shown, in name order