AURAVUE PIT & FISSURE SEALANT— 510(k) K070693

Name: FDA 510(k) clearance K070693
Creator: U.S. Food and Drug Administration
Published: 2007-05-09

Substantially Equivalent

Denali Corporation

FDA 510(k) clearance K070693 for AURAVUE PIT & FISSURE SEALANT, Substantially Equivalent on 2007-05-09. Applicant: Denali Corporation. Device class: 2.

Clearance details

Applicant: Denali Corporation
Product code: Code EBF
Device class: Class 2
Regulation: 21 CFR 872.3690
Advisory panel: Dental
Date received: 2007-03-13
Decision date: 2007-05-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hanover, MA, US

Download summary PDF View on FDA.gov ↗

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