Straumann® PURE Ceramic Implants— 510(k) K241391

Name: FDA 510(k) clearance K241391
Creator: U.S. Food and Drug Administration
Published: 2024-12-10

Substantially Equivalent

Institut Straumann AG

FDA 510(k) clearance K241391 for Straumann® PURE Ceramic Implants, Substantially Equivalent on 2024-12-10. Applicant: Institut Straumann AG. Device class: 2.

Clearance details

Applicant: Institut Straumann AG
Product code: Code DZE
Device class: Class 2
Regulation: 21 CFR 872.3640
Advisory panel: Dental
Date received: 2024-05-15
Decision date: 2024-12-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Basel, CH

Download summary PDF View on FDA.gov ↗

Recent devices under product code DZE

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K260463 — ZEROS Dental Implant System2026-08-19
K251188 — UNIQA® Dental Implants System2026-06-25
K250806 — Dental Implant System2026-06-18
K251232 — MegaGen Zygoma Dental Implant System2026-06-18
K260006 — INOSS System2026-06-17

More clearances from Institut Straumann AG

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K260726 — Straumann® ProClean Cassette (041.800; 041.801)2026-06-03
K260460 — Neodent Gold Hue Custom Abutments, Medentika Custom Abutments Gold Hue2026-05-07
K252168 — Straumann® BLC Implants - Indication Widening2026-03-10
K253315 — Straumann Variobase Abutments XC for Bridge/Bar2026-01-22
K250294 — Straumann® RidgeFit Implants2025-08-12

Adverse events under product code DZE

product code DZE

Death: 28
Injury: 3,367,041
Malfunction: 19,958
Other: 13
Total: 3,387,040

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.