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Dimension Penta H, Dimension Penta H Quick

by Espe Dental AG 510(k)

Active United States

510(k) K000591

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK000591 Date30 Mar 2000ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

1 recall · FDA

    • Terminated Z-0535-2014 FDA Class II initiated 21 Nov 2013

    Specific lots of Imprint II and Paradigm impression material refill packs are being recalled because the moisture displacement feature in both is greatly reduced which may impact the quality of the dental impression.

Specification

510(k)

510(k) Number
FDA Product Code
ELW
Device Class
Class II
Regulation
21 CFR Part 872.3660
Advisory Committee
Dental
FDA Decision
SESE Substantially Equivalent

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