ELOClass I

Cusp, Gold And Stainless Steel

21 CFR 872.3350 / Dental

ELO is the FDA product code for Cusp, Gold And Stainless Steel, a class I device type, regulated under 21 CFR 872.3350. As of 2026-09-10, FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code: ELO
Device name: Cusp, Gold And Stainless Steel
Regulation: 21 CFR 872.3350
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: 0
Ingested recalls: 0

Companies listing this code with FDA

Companies whose registered establishments list this code

Dentimed Sao Joao

Recent clearances

Product code ELO

FDA records hold no clearances under product code ELO.

Recent recalls

Product code ELO

FDA records show no recalls under product code ELO.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device classification database, ingested from openFDA. The definition, regulation number, device class and review panel are FDA’s own fields, reproduced without editing.

MDM adds the counts: clearances by decision year, the applicants holding the most clearances under this code, recalls that name it, and the registered establishments that list it. Every count is computed from ingested records only.

Data as of 2026-10-05, the FDA export date for this dataset. Page last changed 2026-09-05. View this product code on fda.gov (opens on fda.gov)