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Copra Supreme

by Whitepeaks Dental Solutions GmbH

510(k) K233064

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 NumberK233064 Date18 Sep 2024ClearedStatusActive

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  • Withdrawn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.

Copra Supreme 98 with Step is an isostatically pressed zirconia dental material designed for copings and fully anatomical restorations. It features high bending strength (~1100 MPa) and increased translucency, making it suitable for both anterior and posterior teeth restorations, including multi-unit frameworks up to 14 units. Available in white or precoloured variants (A1–D4), it supports natural tooth shading for enhanced aesthetics.

This material is supplied as a dental-grade zirconia block, intended for milling or CAD/CAM fabrication in dental laboratories. It is not classified as single-use or reusable but is regulated under FDA 510(k) clearance (K233064) as a dental device. Storage requirements and sterility are manufacturer-specified, with no explicit MRI safety data provided in the regulatory records. The product carries a lifetime warranty as per manufacturer claims.

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