DD Bio Z, DD Bio ZX(square), DD BioZX(square) color— 510(k) K142987

Name: FDA 510(k) clearance K142987
Creator: U.S. Food and Drug Administration
Published: 2015-02-11

Substantially Equivalent

Dental Direkt of Amerika UG (Haftungsbeschraenkt)

FDA 510(k) clearance K142987 for DD Bio Z, DD Bio ZX(square), DD BioZX(square) color, Substantially Equivalent on 2015-02-11. Applicant: Dental Direkt of Amerika UG (Haftungsbeschraenkt). Device class: 2.

Clearance details

Applicant: Dental Direkt of Amerika UG (Haftungsbeschraenkt)
Product code: Code EIH
Device class: Class 2
Regulation: 21 CFR 872.6660
Advisory panel: Dental
Date received: 2014-10-16
Decision date: 2015-02-11
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Spenge, DE

Download summary PDF View on FDA.gov ↗

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