INTRA-LOCK HYDROXYAPATITE COATED IMPLANTS— 510(k) K031322

Substantially Equivalent

Intra-Lock International

FDA 510(k) clearance K031322 for INTRA-LOCK HYDROXYAPATITE COATED IMPLANTS, Substantially Equivalent on 2003-12-23. Applicant: Intra-Lock International.

Clearance details

Applicant: Intra-Lock International
Product code: Code DZE
Advisory panel: Dental
Date received: 2003-04-25
Decision date: 2003-12-23
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Boca Raton, FL, 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.