S.S. WHITE-PENNWALT PRELUDE PIT SEALANT— 510(k) K801274

Name: FDA 510(k) clearance K801274
Creator: U.S. Food and Drug Administration
Published: 1980-06-09

Substantially Equivalent

Pennwalt Corp.

FDA 510(k) clearance K801274 for S.S. WHITE-PENNWALT PRELUDE PIT SEALANT, Substantially Equivalent on 1980-06-09. Applicant: Pennwalt Corp.. Device class: 2.

Clearance details

Applicant: Pennwalt Corp.
Product code: Code EBC
Device class: Class 2
Regulation: 21 CFR 872.3765
Advisory panel: Dental
Date received: 1980-05-29
Decision date: 1980-06-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, 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.