DD BIO Z AND DD BIO Z - TRANSPA— 510(k) K093748

Name: FDA 510(k) clearance K093748
Creator: U.S. Food and Drug Administration
Published: 2010-02-24

Substantially Equivalent

Dental Direkt of Amerika UG (Haftungsbeschraenkt)

FDA 510(k) clearance K093748 for DD BIO Z AND DD BIO Z - TRANSPA, Substantially Equivalent on 2010-02-24. 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: 2009-12-04
Decision date: 2010-02-24
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Spenge, DE

Download summary PDF View on FDA.gov ↗

Recent devices under product code EIH

view all

K262074 — Any-Zircos2026-08-21
K262239 — Obsidian® Press Over Zirconia2026-07-30
K261046 — Dental Zirconia Blank & Coloring Liquid2026-07-17
K262195 — Dandy Ceramic Stain and Glaze2026-06-30
K260918 — Zolid Lunaris2026-06-29

More clearances from Dental Direkt of Amerika UG (Haftungsbeschraenkt)

view all

K142987 — DD Bio Z, DD Bio ZX(square), DD BioZX(square) color2015-02-11

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