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

Denture, Plastic, Teeth

21 CFR 872.3590 / Dental
FDA source (opens on fda.gov)

ELM is the FDA product code for Denture, Plastic, Teeth, a class II device type, regulated under 21 CFR 872.3590. As of , FDA records hold 55 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
ELM
Device name
Denture, Plastic, Teeth
Regulation
21 CFR 872.3590
Device class
Class II
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
55
Ingested recalls
0

Clearances, product code ELM

By decision year
55 clearances under product code ELM with a decision year between 1977 and 2014, 2006 the highest year at 5.
Show the numbers
510(k) clearances under FDA product code ELM by decision year
YearClearances
19771
19781
19803
19811
19831
19842
19853
19872
19924
19932
19944
19961
19992
20002
20012
20024
20031
20041
20065
20071
20091
20103
20125
20132
20141

Applicants with the most clearances

Product code ELM
Applicants holding the most 510(k) clearances under product code ELM
ApplicantClearances
Ivoclar Vivadent, Inc.5
Dentsply Intl.4
Kulzer GmbH3
Davis Schottlander & Davis, Ltd.2
Ivoclar USA, Inc.2
Merz Dental GmbH2
Oki Shiks USA, Ltd.2
Shofu Dental Corp.2
Austenal Dental, Inc.1
Austenal, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 94 companies shown, in name order