XP BOND DUAL CURE UNIVERSAL TOTAL ETCH ADHESIVE— 510(k) K070538

Name: FDA 510(k) clearance K070538
Creator: U.S. Food and Drug Administration
Published: 2007-03-14

Substantially Equivalent

Dentsply Intl.

FDA 510(k) clearance K070538 for XP BOND DUAL CURE UNIVERSAL TOTAL ETCH ADHESIVE, Substantially Equivalent on 2007-03-14. 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: 2007-02-26
Decision date: 2007-03-14
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.