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All-Ceramic Zirconia Block (K141162)

by Rizhao Huge Dental Industry Co., Ltd.

510(k) K141162

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Abbreviated NumberK141162 Date27 Aug 2014ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

Full name
All-Ceramic Zirconia Block
510(k) Number
FDA Product Code
EIH
Device Class
Class II
Regulation
21 CFR Part 872.6660
Advisory Committee
Dental
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The All-Ceramic Zirconia Block (K141162) is a dental material classified as an all-ceramic dental block, designed for use in dental restorations. It is composed of zirconia powder, a high-strength ceramic material, intended for fabricating dental crowns, bridges, inlays, onlays, and other fixed prosthetics.

This device is supplied as a dental block for milling or layering in dental laboratories and clinics, where it is processed into custom restorations using computer-aided design and manufacturing (CAD/CAM) systems. It is intended for single-use applications and requires sterilization or proper handling before clinical use. The device holds an FDA 510(k) clearance under product code EIH, with a decision date of August 27, 2014.

Other devices from Rizhao Huge Dental Industry Co., Ltd.

Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What types of dental restorations can this zirconia block be used to create, and how is it processed into those restorations?

    The All-Ceramic Zirconia Block is designed for fabricating dental crowns, bridges, inlays, onlays, and other fixed prosthetics. It is processed in dental laboratories or clinics using computer-aided design and manufacturing (CAD/CAM) systems, where it is milled or layered into custom restorations before clinical use.

  • Is this zirconia block intended for single-use or can it be reused after processing?

    The All-Ceramic Zirconia Block is explicitly intended for single-use applications. Once processed into a restoration, it requires sterilization or proper handling before clinical use, indicating it is not meant to be reused in its raw block form.

  • What regulatory pathway was followed for FDA clearance of this zirconia block, and what does that mean for its intended use?

    This device received FDA clearance through a 510(k) submission, classified under product code EIH (Dental Devices) with a decision date of August 27, 2014. The clearance type is 'Abbreviated,' meaning it was determined to be substantially equivalent to a legally marketed predicate device. This pathway confirms its compliance with FDA standards for dental restorative materials.

  • How is the zirconia block supplied, and what are the key considerations for storage or handling before use?

    The All-Ceramic Zirconia Block is supplied as a pre-fabricated dental block, intended for milling or layering in dental labs or clinics. Since it is for single-use, proper storage in a clean, dry environment is critical to maintain its integrity before processing. Handling should follow manufacturer guidelines to avoid contamination or damage before CAD/CAM fabrication.