COLTOSOL TEMPORARY ENDODONTIC FILLING MATERIAL— 510(k) K902392

Name: FDA 510(k) clearance K902392
Creator: U.S. Food and Drug Administration
Published: 1990-08-28

Substantially Equivalent

Coltene, Inc.

FDA 510(k) clearance K902392 for COLTOSOL TEMPORARY ENDODONTIC FILLING MATERIAL, Substantially Equivalent on 1990-08-28. Applicant: Coltene, Inc.. Device class: 2.

Clearance details

Applicant: Coltene, Inc.
Product code: Code EMA
Device class: Class 2
Regulation: 21 CFR 872.3275
Advisory panel: Dental
Date received: 1990-05-30
Decision date: 1990-08-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chicago, IL, US

Download summary PDF View on FDA.gov ↗

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