BTI STERILE DENTAL DRILLS KIT, BTI ABUTMENTS AND CAPS— 510(k) K061383

Substantially Equivalent

B.T.I. Biotechnology Institute, Sl.

FDA 510(k) clearance K061383 for BTI STERILE DENTAL DRILLS KIT, BTI ABUTMENTS AND CAPS, Substantially Equivalent on 2006-08-03. Applicant: B.T.I. Biotechnology Institute, Sl..

Clearance details

Applicant
B.T.I. Biotechnology Institute, Sl.
Product code
Code EJL
Advisory panel
Dental
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Minano(Alava), ES
Download summary PDFView on FDA.gov ↗

Adverse events under product code EJL

product code EJL
Other
1
Total
1

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.