PRIME & BOND NT DUAL CURE NANO-TECHNOLOGY UNIVERSAL DENTAL ADHESIVE SYSTEM— 510(k) K050386

Name: FDA 510(k) clearance K050386
Creator: U.S. Food and Drug Administration
Published: 2005-02-23

Substantially Equivalent

Dentsply International

FDA 510(k) clearance K050386 for PRIME & BOND NT DUAL CURE NANO-TECHNOLOGY UNIVERSAL DENTAL ADHESIVE SYSTEM, Substantially Equivalent on 2005-02-23. Applicant: Dentsply International. Device class: 2.

Clearance details

Applicant: Dentsply International
Product code: Code KLE
Device class: Class 2
Regulation: 21 CFR 872.3200
Advisory panel: Dental
Date received: 2005-02-15
Decision date: 2005-02-23
Decision: Substantially Equivalent
Clearance type: Special
Location: York, PA, 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.