SGS DENTAL IMPLANT— 510(k) K133362

Name: FDA 510(k) clearance K133362
Creator: U.S. Food and Drug Administration
Published: 2014-11-21

Substantially Equivalent

Sgs International, Ltd.

FDA 510(k) clearance K133362 for SGS DENTAL IMPLANT, Substantially Equivalent on 2014-11-21. Applicant: Sgs International, Ltd.. Device class: 2.

Clearance details

Applicant: Sgs International, Ltd.
Product code: Code DZE
Device class: Class 2
Regulation: 21 CFR 872.3640
Advisory panel: Dental
Date received: 2013-11-01
Decision date: 2014-11-21
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Woodland Hills, CA, US

Download summary PDF View on FDA.gov ↗

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K260006 — INOSS System2026-06-17

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K182219 — SGS Dental Implants System2019-08-29

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.