DIMENSION PENTA H, DIMENSION PENTA H QUICK— 510(k) K000591

Name: FDA 510(k) clearance K000591
Creator: U.S. Food and Drug Administration
Published: 2000-03-30

Substantially Equivalent

Espe Dental AG

FDA 510(k) clearance K000591 for DIMENSION PENTA H, DIMENSION PENTA H QUICK, Substantially Equivalent on 2000-03-30. Applicant: Espe Dental AG. Device class: 2.

Clearance details

Applicant: Espe Dental AG
Product code: Code ELW
Device class: Class 2
Regulation: 21 CFR 872.3660
Advisory panel: Dental
Date received: 2000-02-22
Decision date: 2000-03-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bavaria D-82228 Seefeld, DE

Download summary PDF View on FDA.gov ↗

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K002793 — KETAC CEM U2000-09-26
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K001494 — MODIFICATION TO PROMPT L-POP2000-07-07

Recalls naming K000591

K-number listed on FDA's recall record

Z-0535-2014 — 3M ESPE Imprint II Regular Body , Catalog Number 9379, and Paradigm Regular Body VPS, Catalog Number 5315, Impression Material that are intended to reproduce the structure of a patients teeth. Impression Materials are composed of hydrophilic vinyl polysiloxane impression materials, designed for making precise crown and bridge, inlay, onlay, veneer preparations, removable denture and partial denture impressions.Class II·Terminated·3M Company - Health Care Business·20131121

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K000591.

Data sourced from openFDA. This site is unofficial and independent of the FDA.