IMCOR 3.75 AND 5.00MM EXTERNALLY HEXED, SELF TAPPING HA COATED SCREW IMPLANTS WITH COVER SCREW— 510(k) K974126

Substantially Equivalent

Imcor

FDA 510(k) clearance K974126 for IMCOR 3.75 AND 5.00MM EXTERNALLY HEXED, SELF TAPPING HA COATED SCREW IMPLANTS WITH COVER SCREW, Substantially Equivalent on 1998-01-30. Applicant: Imcor.

Clearance details

Applicant: Imcor
Product code: Code DZE
Advisory panel: Dental
Date received: 1997-11-03
Decision date: 1998-01-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Edina, 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.