DENCLENZ— 510(k) K854995

Substantially Equivalent

Creighton Products Corp.

FDA 510(k) clearance K854995 for DENCLENZ, Substantially Equivalent on 1986-05-12. Applicant: Creighton Products Corp..

Clearance details

Applicant: Creighton Products Corp.
Product code: Code EFT
Advisory panel: Dental
Date received: 1985-12-12
Decision date: 1986-05-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New York, NY, 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.