Prosthetic devices · 21 CFR 872 Subpart D

Preformed Cusp

FDA device type “Cusp, Preformed”.

FDA codeEHQClass121 CFR872.3360Pathway510(k) exempt
Companies listing it
21 makers
Brands and models
2
510(k) clearances
00 in five years
FDA name
Cusp, Preformed

Companies that list EHQ

2 companies currently list this device type with FDA.

CompanyCountryRoleBrands and models listedClearancesLatest
Voco GmbHGermanyMakerRebilda Form1172026
Dentimed Sao Joao LLCUnited StatesRepacker / relabelerTORINO——

Official records: FDA product classification for EHQ · 21 CFR 872.3360.

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