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Gc Aadva Zr Disk

by Gc America Inc.

510(k) K082740

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 · Special NumberK082740 Date26 Nov 2008ClearedStatusActive

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  • Withdrawn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
FDA applicant
GC America, Inc.
Device class
Class II
Regulation
21 CFR Part 872.6660
Advisory committee
Dental
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 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 GC Aadva Zr Disk is a dental material composed of zirconia. It is used by dental laboratory technicians to fabricate crown and bridge frameworks for both anterior and posterior applications.

This device is classified as a Class 2 dental product under product code EIH. It received FDA 510(k) clearance on November 26, 2008, under the special 510(k) pathway.

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