DTX Studio Clinic 3.0— 510(k) K213562

Substantially Equivalent

Nobel Biocare AB

FDA 510(k) clearance K213562 for DTX Studio Clinic 3.0, Substantially Equivalent on 2022-03-25. Applicant: Nobel Biocare AB.

Clearance details

Applicant: Nobel Biocare AB
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2021-11-09
Decision date: 2022-03-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: 411 17 Goteborg, SE

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.