EXCITE F AND EXCITE DSC— 510(k) K093744

Substantially Equivalent

Ivoclar Vivadent, Inc.

FDA 510(k) clearance K093744 for EXCITE F AND EXCITE DSC, Substantially Equivalent on 2010-03-10. Applicant: Ivoclar Vivadent, Inc.. Device class: 2.

Clearance details

Applicant: Ivoclar Vivadent, Inc.
Product code: Code KLE
Device class: Class 2
Regulation: 21 CFR 872.3200
Advisory panel: Dental
Date received: 2009-12-04
Decision date: 2010-03-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Amherst, NY, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K093744

K-number listed on FDA's recall record

Z-0376-2014 — ExciTE F DSC Soft touch Single Dose, Dual-curing Regular Ref. 50 dental adhesive for restorationsClass II·Terminated·Ivoclar Vivadent, Inc.·20130923

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K093744.

Data sourced from openFDA. This site is unofficial and independent of the FDA.