PRIME & BOND NT DUAL CURE UNIVERSAL DENTAL ADHESIVE SYSTEM— 510(k) K982394

Name: FDA 510(k) clearance K982394
Creator: U.S. Food and Drug Administration
Published: 1998-09-21

Substantially Equivalent

Dentsply Intl.

FDA 510(k) clearance K982394 for PRIME & BOND NT DUAL CURE UNIVERSAL DENTAL ADHESIVE SYSTEM, Substantially Equivalent on 1998-09-21. Applicant: Dentsply Intl.. Device class: 2.

Clearance details

Applicant: Dentsply Intl.
Product code: Code KLE
Device class: Class 2
Regulation: 21 CFR 872.3200
Advisory panel: Dental
Date received: 1998-07-09
Decision date: 1998-09-21
Decision: Substantially Equivalent
Clearance type: Traditional
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.