TORX HANDPIECE CONTRA ANGLES ATTACHMENTS— 510(k) K801688

Substantially Equivalent

Pacific Dental Corp.

FDA 510(k) clearance K801688 for TORX HANDPIECE CONTRA ANGLES ATTACHMENTS, Substantially Equivalent on 1980-08-04. Applicant: Pacific Dental Corp..

Clearance details

Applicant
Pacific Dental Corp.
Product code
Code EGS
Advisory panel
Dental
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Mchenry, IL, 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.