SPI ELEMENT DENTAL IMPLANT O 3.5 MM— 510(k) K030689

Name: FDA 510(k) clearance K030689
Creator: U.S. Food and Drug Administration
Published: 2003-03-26

Substantially Equivalent

Thommen Medical AG

FDA 510(k) clearance K030689 for SPI ELEMENT DENTAL IMPLANT O 3.5 MM, Substantially Equivalent on 2003-03-26. Applicant: Thommen Medical AG. Device class: 2.

Clearance details

Applicant: Thommen Medical AG
Product code: Code DZE
Device class: Class 2
Regulation: 21 CFR 872.3640
Advisory panel: Dental
Date received: 2003-03-05
Decision date: 2003-03-26
Decision: Substantially Equivalent
Clearance type: Special
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DZE

view all

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 Thommen Medical AG

view all

K171795 — Thommen Implant System2017-09-29
K160244 — VARIOunite2016-06-02
K151984 — Thommen Milling Abutment for CAD/CAM2016-03-10
K121334 — VARIOECO2012-08-14
K111984 — SPI VARIO ANGLED ABUTMENT2011-11-10

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.