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Pisces Plus (DW286 C)

by Ivoclar Vivadent, Inc.

510(k) K020183

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 NumberK020183 Date13 Mar 2002ClearedStatusActive

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  • Withdrawn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
EJH
Device class
Class II
Regulation
21 CFR Part 872.3710
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.

Pisces Plus (DW286 C) is a base metal alloy used by dental professionals for the fabrication of dental restorations. It is intended for use in creating onlays, partial crowns, telescope crowns, conus crowns, posts, short and long span bridges, and PFM crowns.

The device is supplied by Ivoclar Vivadent, Inc. and is classified as a Class II medical device under FDA regulation 872.3710. It received traditional 510(k) clearance (K020183) on March 13, 2002, and is substantially equivalent to a legally marketed predicate device.

Other devices from Ivoclar Vivadent, Inc.

See all devices from Ivoclar Vivadent, Inc. →

Questions

AI-generated answers, 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.

  • What is Pisces Plus (DW286 C) used for?

    Pisces Plus (DW286 C) is a base metal alloy used by dental professionals to fabricate dental restorations such as onlays, partial crowns, telescope crowns, conus crowns, posts, short and long span bridges, and PFM crowns. It is intended for use in creating these specific types of dental prosthetics.

  • How is Pisces Plus (DW286 C) supplied and what is its classification?

    Pisces Plus (DW286 C) is supplied by Ivoclar Vivadent, Inc. and is classified as a Class II medical device under FDA regulation 872.3710. It is provided as a dental alloy material for use in restoration fabrication.

  • What regulatory clearance does Pisces Plus (DW286 C) have?

    Pisces Plus (DW286 C) received traditional 510(k) clearance (K020183) from the FDA on March 13, 2002, and is substantially equivalent to a legally marketed predicate device. This clearance allows it to be legally marketed in the United States for its intended use.