INCLUSIVE TITANIUM ABUTMENTS COMPATIBLE WITH STRAUMANN TISSUE LEVEL IMPLANTS— 510(k) K141211

Substantially Equivalent

Prismatik Dentalcraft, Inc.

FDA 510(k) clearance K141211 for INCLUSIVE TITANIUM ABUTMENTS COMPATIBLE WITH STRAUMANN TISSUE LEVEL IMPLANTS, Substantially Equivalent on 2014-10-22. Applicant: Prismatik Dentalcraft, Inc..

Clearance details

Applicant: Prismatik Dentalcraft, Inc.
Product code: Code NHA
Advisory panel: Dental
Date received: 2014-05-09
Decision date: 2014-10-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

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.