TDS ZIRCONIA ABUTMENT FOR NOBEL BIOCARE BRANEMARK— 510(k) K091693

Clearance details

Applicant

Pou YU Biotechnology Co., Ltd.

Product code

Code NHA

Device class

Class 2

Regulation

21 CFR 872.3630

Advisory panel

Dental

Date received

2009-06-10

Decision date

2009-07-30

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Fusing Township, Changhua Cty, TW

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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 →