IMCOR 4.00 & 5.00MM SELF-TAPPING LOCKTITE IMPLANTS, IMCOR 4.00 & 5.00MM SELF-TAPPING HA COASTED LOCKTITE IMPLANTS, AND I— 510(k) K983563

Substantially Equivalent

Imcor

FDA 510(k) clearance K983563 for IMCOR 4.00 & 5.00MM SELF-TAPPING LOCKTITE IMPLANTS, IMCOR 4.00 & 5.00MM SELF-TAPPING HA COASTED LOCKTITE IMPLANTS, AND I, Substantially Equivalent on 1999-01-11. Applicant: Imcor.

Clearance details

Applicant: Imcor
Product code: Code DZE
Advisory panel: Dental
Date received: 1998-10-13
Decision date: 1999-01-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minneapolis, MN, 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.