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

Implant, Subperiosteal

21 CFR 872.3645 / Dental
FDA source (opens on fda.gov)

ELE is the FDA product code for Implant, Subperiosteal, a class II device type, regulated under 21 CFR 872.3645. As of , FDA records hold 4 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
ELE
Device name
Implant, Subperiosteal
Regulation
21 CFR 872.3645
Device class
Class II
Review panel
Dental
Submission type
510(k)
Implant
Yes
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
4
Ingested recalls
0

Clearances, product code ELE

By decision year
4 clearances under product code ELE with a decision year between 1980 and 2022, 1980 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code ELE by decision year
YearClearances
19801
19841
19861
20221

Applicants with the most clearances

Product code ELE
Applicants holding the most 510(k) clearances under product code ELE
ApplicantClearances
Colmed, Ltd.1
Jeneric Ind.1
KLS-Martin L.P.1
Katecho LLC1

Companies listing this code with FDA

Companies whose registered establishments list this code