SL3— 510(k) K102639

Substantially Equivalent

Discus Dental, LLC

FDA 510(k) clearance K102639 for SL3, Substantially Equivalent on 2010-12-01. Applicant: Discus Dental, LLC.

Clearance details

Applicant: Discus Dental, LLC
Product code: Code GEX
Advisory panel: General, Plastic Surgery
Date received: 2010-09-14
Decision date: 2010-12-01
Decision: Substantially Equivalent
Clearance type: Special
Location: Culver City, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code GEX

product code GEX

Death: 33
Injury: 3,045
Malfunction: 12,903
Other: 25
Total: 16,006

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.