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HCG Zirconia Ceramic Block

by Hocheng Corporation

510(k) K193090

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 · Traditional NumberK193090 Date29 Oct 2020ClearedStatusActive

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  • Withdrawn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)

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, 1 Oct 2026

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

The HCG Zirconia Ceramic Block is a dental ceramic material classified as porcelain powder for clinical use (21 CFR 872.6660). Composed of zirconia compounds (ZrO₂, Y₂O₃, Al₂O₃), it is designed for the fabrication of dental restorations, including copings, full anatomical crowns, bridges, inlays, and onlays for both anterior and posterior segments. Its high-strength ceramic formulation supports precise milling and sintering processes in dental laboratories.

Supplied as a reusable block, the HCG Zirconia Ceramic Block is intended for use in dental laboratories under controlled conditions. It is not sterile at time of shipment and must be processed according to manufacturer guidelines prior to clinical application. The device adheres to FDA 510(k) clearance (K193090) under the Dental advisory committee (DE) and falls under Product Code EIH. Storage and handling follow standard dental ceramic protocols to maintain material integrity.

Questions

AI-generated answers, 1 Oct 2026

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

  • What is the HCG Zirconia Ceramic Block used for in dental restorations?

    The HCG Zirconia Ceramic Block is designed for fabricating high-strength dental restorations, including copings, full anatomical crowns, bridges, inlays, and onlays. Its zirconia-based composition (ZrO₂, Y₂O₃, Al₂O₃) supports precise milling and sintering in dental laboratories, ensuring durability for both anterior and posterior segments.

  • Is the HCG Zirconia Ceramic Block sterile when received?

    No, the HCG Zirconia Ceramic Block is not sterile at the time of shipment. It must be processed according to the manufacturer’s guidelines before clinical use to ensure proper sterility and safety.

  • How is the HCG Zirconia Ceramic Block supplied, and can it be reused?

    The HCG Zirconia Ceramic Block is supplied as a reusable block intended for use in dental laboratories under controlled conditions. Its design allows for repeated milling and processing cycles, provided it adheres to standard ceramic handling protocols to maintain material integrity.

  • What regulatory approval does the HCG Zirconia Ceramic Block hold?

    The HCG Zirconia Ceramic Block holds FDA 510(k) clearance (K193090) under the Dental Advisory Committee (DE) and falls under Product Code EIH. This clearance confirms its substantial equivalence to a predicate device.

  • How should the HCG Zirconia Ceramic Block be stored?

    Storage follows standard dental ceramic protocols to preserve material integrity. The block should be kept in a clean, dry environment away from moisture, extreme temperatures, or contaminants that could compromise its structural properties or sterility before processing.