TRIPLE-CURE PASTE/PASTE RESIN-REINFORCED GLASS IONOMER CEMENT— 510(k) K030036

Name: FDA 510(k) clearance K030036
Creator: U.S. Food and Drug Administration
Published: 2003-03-12

Substantially Equivalent

Pulpdent Corporation

FDA 510(k) clearance K030036 for TRIPLE-CURE PASTE/PASTE RESIN-REINFORCED GLASS IONOMER CEMENT, Substantially Equivalent on 2003-03-12. Applicant: Pulpdent Corporation. Device class: 2.

Clearance details

Applicant: Pulpdent Corporation
Product code: Code DYH
Device class: Class 2
Regulation: 21 CFR 872.3750
Advisory panel: Dental
Date received: 2003-01-03
Decision date: 2003-03-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Watertown, MA, 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.