ANAXBLEND MODEL 20XXX (SEVERAL), ANAXGUM MODEL 25XXX (U), MOCK-UP DIRECT MODEL 240XXX (U), MOCK-UP DIRECT FLOW MODEL 24A— 510(k) K112044

Substantially Equivalent

Anaxdent GmbH

FDA 510(k) clearance K112044 for ANAXBLEND MODEL 20XXX (SEVERAL), ANAXGUM MODEL 25XXX (U), MOCK-UP DIRECT MODEL 240XXX (U), MOCK-UP DIRECT FLOW MODEL 24A, Substantially Equivalent on 2012-01-26. Applicant: Anaxdent GmbH. Device class: 2.

Clearance details

Applicant: Anaxdent GmbH
Product code: Code EBF
Device class: Class 2
Regulation: 21 CFR 872.3690
Advisory panel: Dental
Date received: 2011-07-18
Decision date: 2012-01-26
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Tarpley, TX, US

Download summary PDF View on FDA.gov ↗

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More clearances from Anaxdent GmbH

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