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ALL-CERAMIC ZIRCONIA BLOCK

K141162 Class II Abbreviated
Decision Date
2014-08-27
Sponsor / Applicant
Rizhao Huge Dental Industry Co., Ltd.

Technical Specification

510(k) Submission ID K141162
Product Code EIH
Medical Specialty / Panel Dental
Regulation Citation 21 CFR 872.6660
Decision Date 2014-08-27
Clearance Pathway Abbreviated

Official Documentation

FDA CDRH Summary / statement of record

View FDA Summary PDF

Clearance Summary

ALL-CERAMIC ZIRCONIA BLOCK received FDA 510(k) clearance under submission number K141162, sponsored by Rizhao Huge Dental Industry Co., Ltd.. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2014-08-27.

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.