510(k) K252976— Park Dental Nylon MAD

Substantially Equivalent

Park Dental Research Corp.

Clearance details

Applicant: Park Dental Research Corp.
Product code: Code LRK
Advisory panel: Dental
Date received: 2025-09-17
Decision date: 2025-12-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ardmore, OK, US

Adverse events under product code LRK

product code LRK

Injury: 246
Malfunction: 1,044
Total: 1,290

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.