meddevicedb.com FDA Device Reference

Vericore Zirconia Blanks

K142670 Class II Special
Decision Date
2014-10-22
Sponsor / Applicant
Whip Mix Corporation

Technical Specification

510(k) Submission ID K142670
Product Code EIH
Medical Specialty / Panel Dental
Regulation Citation 21 CFR 872.6660
Decision Date 2014-10-22
Clearance Pathway Special

Official Documentation

FDA CDRH Summary / statement of record

View FDA Summary PDF

Clearance Summary

Vericore Zirconia Blanks received FDA 510(k) clearance under submission number K142670, sponsored by Whip Mix Corporation. The device was reviewed via the Special premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2014-10-22.

Classification & Regulation

This clearance is catalogued under FDA product code EIH and 21 CFR 872.6660, within the Dental review panel as a Class II device.