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

Teeth, Preformed Gold Denture

21 CFR 872.3580 / Dental
FDA source (opens on fda.gov)

ELN is the FDA product code for Teeth, Preformed Gold Denture, a class I device type, regulated under 21 CFR 872.3580. As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
ELN
Device name
Teeth, Preformed Gold Denture
Regulation
21 CFR 872.3580
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
1
Ingested recalls
0

Clearances, product code ELN

By decision year
1 clearance under product code ELN with a decision year between 1977 and 1977, 1977 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code ELN by decision year
YearClearances
19771

Applicants with the most clearances

Product code ELN
Applicants holding the most 510(k) clearances under product code ELN
ApplicantClearances
Espe GmbH (US)1

Companies listing this code with FDA

Companies whose registered establishments list this code