DIMENSION GARANT L, DIMENSION GARANT L QUICK— 510(k) K000588

Name: FDA 510(k) clearance K000588
Creator: U.S. Food and Drug Administration
Published: 2000-03-30

Substantially Equivalent

Espe Dental AG

FDA 510(k) clearance K000588 for DIMENSION GARANT L, DIMENSION GARANT L QUICK, Substantially Equivalent on 2000-03-30. Applicant: Espe Dental AG. Device class: 2.

Clearance details

Applicant: Espe Dental AG
Product code: Product 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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