TDS TITANIUM ABUTMENT FOR NOBEL BIOCARE BRANEMARK— 510(k) K091392

Substantially Equivalent

Pou YU Biotechnology Co., Ltd.

FDA 510(k) clearance K091392 for TDS TITANIUM ABUTMENT FOR NOBEL BIOCARE BRANEMARK, Substantially Equivalent on 2009-07-30. Applicant: Pou YU Biotechnology Co., Ltd..

Clearance details

Applicant: Pou YU Biotechnology Co., Ltd.
Product code: Code NHA
Advisory panel: Dental
Date received: 2009-05-11
Decision date: 2009-07-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fusing Township, Changhua Cty, TW

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.