MTA-FILLAPEX— 510(k) K113568

Substantially Equivalent

Paxmed International

FDA 510(k) clearance K113568 for MTA-FILLAPEX, Substantially Equivalent on 2012-08-21. Applicant: Paxmed International. Device class: 2.

Clearance details

Applicant: Paxmed International
Product code: Code KIF
Device class: Class 2
Regulation: 21 CFR 872.3820
Advisory panel: Dental
Date received: 2011-12-02
Decision date: 2012-08-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

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More clearances from Paxmed International

K022038 — SPI ONETIME DENTAL IMPLANT2002-07-15
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Data sourced from openFDA. This site is unofficial and independent of the FDA.