ROTORY SCALER SWIVEL IMPROVEMENT FEATURE, TITAN SW— 510(k) K881253

Substantially Equivalent

Dentalez Group

FDA 510(k) clearance K881253 for ROTORY SCALER SWIVEL IMPROVEMENT FEATURE, TITAN SW, Substantially Equivalent on 1988-04-21. Applicant: Dentalez Group.

Clearance details

Applicant: Dentalez Group
Product code: Code ELC
Advisory panel: Dental
Date received: 1988-03-23
Decision date: 1988-04-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lancaster, PA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code ELC

product code ELC

Malfunction: 1,255
Total: 1,255

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.