Inclusive Titanium Abutments compatible with: Hiossen HG Implant System— 510(k) K151375

Name: FDA 510(k) clearance K151375
Creator: U.S. Food and Drug Administration
Published: 2015-10-07

Substantially Equivalent

Prismatik Dentalcraft, Inc.

FDA 510(k) clearance K151375 for Inclusive Titanium Abutments compatible with: Hiossen HG Implant System, Substantially Equivalent on 2015-10-07. Applicant: Prismatik Dentalcraft, Inc.. Device class: 2.

Clearance details

Applicant: Prismatik Dentalcraft, Inc.
Product code: Code NHA
Device class: Class 2
Regulation: 21 CFR 872.3630
Advisory panel: Dental
Date received: 2015-05-22
Decision date: 2015-10-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

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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.