SIMPLANT ORTHO; VISTADENT 3D— 510(k) K081402

Name: FDA 510(k) clearance K081402
Creator: U.S. Food and Drug Administration
Published: 2008-07-18

Substantially Equivalent

Materialise Dental NV

FDA 510(k) clearance K081402 for SIMPLANT ORTHO; VISTADENT 3D, Substantially Equivalent on 2008-07-18. Applicant: Materialise Dental NV. Device class: 2.

Clearance details

Device name as filed: SIMPLANT ORTHO ; VISTADENT 3D
Applicant: Materialise Dental NV
Product code: Code LLZ
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2008-05-19
Decision date: 2008-07-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Leuven, BE

Download summary PDF View on FDA.gov ↗

Recent devices under product code LLZ

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K120733 — SIMPLANT GO2012-07-05
K113739 — SIMPLANT IMMEDIATE SMILE DENTAL CARE SYSTEM2012-05-30
K112679 — SIMPLANT NAVIGATOR PERSONALIZED DENTAL CARE SYSTEM2012-02-22
K110300 — SIMPLANT 20112011-07-01

Adverse events under product code LLZ

product code LLZ

Death: 13
Total: 13

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

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