510(k) K121688— MULTI-UNIT ABUTMENTS WITH ANGULATIONS 17 AND 30 FOR TAPERED IMPLANT SYSTEM

Substantially Equivalent

Prismatik Dentalcraft, Inc.

Clearance details

Applicant: Prismatik Dentalcraft, Inc.
Product code: Code NHA
Advisory panel: Dental
Date received: 2012-06-07
Decision date: 2012-10-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

Adverse events under product code NHA

product code NHA

Injury: 1,270
Malfunction: 2,860
Total: 4,130

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.