LYNX-HIGH SPEED HANDPIECE— 510(k) K895736

Substantially Equivalent

Mti Precision Products

FDA 510(k) clearance K895736 for LYNX-HIGH SPEED HANDPIECE, Substantially Equivalent on 1989-12-18. Applicant: Mti Precision Products.

Clearance details

Applicant
Mti Precision Products
Product code
Code EFB
Advisory panel
Dental
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Lakewood, NJ, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code EFB

product code EFB
Injury
133
Malfunction
562
Total
695

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.