INTRA-LOCK OP DENTAL IMPLANT— 510(k) K130140

Substantially Equivalent

Intra-Lock International

FDA 510(k) clearance K130140 for INTRA-LOCK OP DENTAL IMPLANT, Substantially Equivalent on 2013-08-01. Applicant: Intra-Lock International.

Clearance details

Applicant: Intra-Lock International
Product code: Code DZE
Advisory panel: Dental
Date received: 2013-01-22
Decision date: 2013-08-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Boca Raton, FL, US

Download summary PDF View on FDA.gov ↗

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.