MEDENTAL CHEMICAL CURING SEALANT PIT & FISSURE TINTED— 510(k) K973541

Name: FDA 510(k) clearance K973541
Creator: U.S. Food and Drug Administration
Published: 1997-11-25

Substantially Equivalent

Medental Intl.

FDA 510(k) clearance K973541 for MEDENTAL CHEMICAL CURING SEALANT PIT & FISSURE TINTED, Substantially Equivalent on 1997-11-25. Applicant: Medental Intl.. Device class: 2.

Clearance details

Applicant: Medental Intl.
Product code: Code EBC
Device class: Class 2
Regulation: 21 CFR 872.3765
Advisory panel: Dental
Date received: 1997-09-18
Decision date: 1997-11-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Evergreen, CO, US

Download summary PDF View on FDA.gov ↗

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