ULTRADENT PRODUCT PIT & FISSURE SEALANT PROD LINE— 510(k) K921598

Name: FDA 510(k) clearance K921598
Creator: U.S. Food and Drug Administration
Published: 1992-09-09

Substantially Equivalent

Ultradent Products, Inc.

FDA 510(k) clearance K921598 for ULTRADENT PRODUCT PIT & FISSURE SEALANT PROD LINE, Substantially Equivalent on 1992-09-09. Applicant: Ultradent Products, Inc.. Device class: 2.

Clearance details

Applicant: Ultradent Products, Inc.
Product code: Code EBF
Device class: Class 2
Regulation: 21 CFR 872.3690
Advisory panel: Dental
Date received: 1992-04-03
Decision date: 1992-09-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Salt Lake City, UT, 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.