STRAIGHT ABUTMENT, 4.2, 4.6, 5.0, 6.4, IMPLANT 6.0, IMPLANT 7.0, IMPLANT 8.0 MODEL: 002061, 002062, 002063, 002064,— 510(k) K101201

Substantially Equivalent

Kat Implants, LLC

FDA 510(k) clearance K101201 for STRAIGHT ABUTMENT, 4.2, 4.6, 5.0, 6.4, IMPLANT 6.0, IMPLANT 7.0, IMPLANT 8.0 MODEL: 002061, 002062, 002063, 002064,, Substantially Equivalent on 2011-04-13. Applicant: Kat Implants, LLC.

Clearance details

Applicant: Kat Implants, LLC
Product code: Code DZE
Advisory panel: Dental
Date received: 2010-04-29
Decision date: 2011-04-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Portsmouth, NH, US

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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.