SR-IVOCAP— 510(k) K896130

Substantially Equivalent

Ivoclar North America, Inc.

FDA 510(k) clearance K896130 for SR-IVOCAP, Substantially Equivalent on 1990-04-16. Applicant: Ivoclar North America, Inc..

Clearance details

Applicant
Ivoclar North America, Inc.
Product code
Code EBI
Advisory panel
Dental
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Amherst, NY, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code EBI

product code EBI
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.