Prosthetic devices · 21 CFR 872 Subpart D

Gold and Stainless Steel Cusp

FDA device type “Cusp, Gold And Stainless Steel”.

FDA codeELOClass121 CFR872.3350Pathway510(k) exempt
Companies listing it
10 makers
Brands and models
1
510(k) clearances
00 in five years
FDA name
Cusp, Gold And Stainless Steel

Companies that list ELO

1 company currently list this device type with FDA.

CompanyCountryRoleBrands and models listedClearancesLatest
Dentimed Sao Joao LLCUnited StatesRepacker / relabelerORTHOM——

Official records: FDA product classification for ELO · 21 CFR 872.3350.

Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026