IMPLANTMASTER— 510(k) K042212

Substantially Equivalent

I-Dent

FDA 510(k) clearance K042212 for IMPLANTMASTER, Substantially Equivalent on 2004-10-21. Applicant: I-Dent.

Clearance details

Applicant: I-Dent
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2004-08-16
Decision date: 2004-10-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hod Hasharon, IL

Download summary PDF View on FDA.gov ↗

Adverse events under product code LLZ

product code LLZ

Death: 13
Total: 13

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.