SYNSPAR ADVANCED— 510(k) K123613

Substantially Equivalent

Ardent, Inc.

FDA 510(k) clearance K123613 for SYNSPAR ADVANCED, Substantially Equivalent on 2013-02-20. Applicant: Ardent, Inc.. Device class: 2.

Clearance details

Applicant: Ardent, Inc.
Product code: Code EIH
Device class: Class 2
Regulation: 21 CFR 872.6660
Advisory panel: Dental
Date received: 2012-11-23
Decision date: 2013-02-20
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Amherst, NY, 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.