REPLACE ONE PIECE IMPLANT, HA, REPLACE ONE PIECE IMPLANT, TIUNITE— 510(k) K023952

Substantially Equivalent

Nobel Biocare Uas, Inc.

FDA 510(k) clearance K023952 for REPLACE ONE PIECE IMPLANT, HA, REPLACE ONE PIECE IMPLANT, TIUNITE, Substantially Equivalent on 2003-01-16. Applicant: Nobel Biocare Uas, Inc..

Clearance details

Applicant: Nobel Biocare Uas, Inc.
Product code: Code DZE
Advisory panel: Dental
Date received: 2002-11-27
Decision date: 2003-01-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Yorba Linda,, CA, US

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Adverse events under product code DZE

product code DZE

Death: 28
Injury: 3,367,041
Malfunction: 19,958
Other: 13
Total: 3,387,040

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.