ISY— 510(k) K133991

Name: FDA 510(k) clearance K133991
Creator: U.S. Food and Drug Administration
Published: 2014-08-06

Substantially Equivalent

Altatec GmbH

FDA 510(k) clearance K133991 for ISY, Substantially Equivalent on 2014-08-06. Applicant: Altatec GmbH. Device class: 2.

Clearance details

Applicant: Altatec GmbH
Product code: Code DZE
Device class: Class 2
Regulation: 21 CFR 872.3640
Advisory panel: Dental
Date received: 2013-12-26
Decision date: 2014-08-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

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 Altatec GmbH

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K193401 — Altatec GmbH CAMLOG/CONELOG PROGRESSIVE-LINE Implants2020-09-29
K160784 — CAM Titanium Blanks2016-09-14
K153779 — Abutment for Bridges2016-03-31
K152509 — CAMLOG and CONELOG Abutments for Screw-retained Restorations (ASR)2016-01-12
K151599 — iSy Implant System2015-10-02

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.