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Carrara Volumia

by Dentsply Intl.

510(k) K070019

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 NumberK070019 Date26 Jan 2007ClearedStatusActive

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  • Withdrawn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, 19 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 Carrara Volumia Ceramic System is a dental powder used for fabricating porcelain restorations, classified under the nomenclature for powder, porcelain. It is designed for dental applications, including crowns, bridges, and other prosthetic restorations, leveraging ceramic materials to achieve durable and aesthetically pleasing dental repairs.

This system is supplied as a dental-grade ceramic powder and is intended for single-use in clinical settings. It is regulated under FDA 510(k) clearance (K070019) with a Substantially Equivalent determination, adhering to dental classification standards. Storage and handling follow standard dental protocols for ceramic materials, ensuring sterility and compatibility with dental laboratory procedures.

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