STARDENTAL TITAN 3 LUBEFREE MOTOR ATTACHMENTS— 510(k) K983574

Substantially Equivalent

Dentalez Group

FDA 510(k) clearance K983574 for STARDENTAL TITAN 3 LUBEFREE MOTOR ATTACHMENTS, Substantially Equivalent on 1999-01-08. Applicant: Dentalez Group.

Clearance details

Applicant
Dentalez Group
Product code
Code EGS
Advisory panel
Dental
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Lancaster, PA, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code EGS

product code EGS
Injury
356
Malfunction
759
Total
1,115

Source: openFDA MAUDE database, through . 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.