CLEAN DENT— 510(k) K890668

Substantially Equivalent

Lincoln Park Dental Laboratory

FDA 510(k) clearance K890668 for CLEAN DENT, Substantially Equivalent on 1989-04-17. Applicant: Lincoln Park Dental Laboratory.

Clearance details

Applicant: Lincoln Park Dental Laboratory
Product code: Code EFT
Advisory panel: Dental
Date received: 1989-02-09
Decision date: 1989-04-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: York, PA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code EFT

product code EFT

Death: 8
Injury: 267
Total: 275

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.