SPECTRA FORM CHROMATIC ALGINATE IMPRESSION MATERIAL— 510(k) K980965

Name: FDA 510(k) clearance K980965
Creator: U.S. Food and Drug Administration
Published: 1998-05-01

Substantially Equivalent

Cavex Holland BV

FDA 510(k) clearance K980965 for SPECTRA FORM CHROMATIC ALGINATE IMPRESSION MATERIAL, Substantially Equivalent on 1998-05-01. Applicant: Cavex Holland BV. Device class: 2.

Clearance details

Applicant: Cavex Holland BV
Product code: Product code ELW
Device class: Class 2
Regulation: 21 CFR 872.3660
Advisory panel: Dental
Date received: 1998-03-16
Decision date: 1998-05-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Harmen, NL

Download summary PDF View on FDA.gov ↗

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