510(k) clearance

Zirconia Collective 4Y Dental Zirconia Blank

FDA 510(k) source

510(k) number

K262685

Applicant

Zirconia Collective, Inc.

Decision date

Oct 30, 2026

Date received

Jul 31, 2026

Decision

Substantially Equivalent

Clearance type

Traditional

Product code

EIH

Device type

Powder, Porcelain

Device class

Class II

Regulation

21 CFR 872.6660

Advisory committee

Dental

Statement or summary

Summary

Third party

N

Location

Westminster, CO, US