BRINK PRE-MAXILLARY IMPLANT— 510(k) K921580

Substantially Equivalent

Implantech Associates, Inc.

FDA 510(k) clearance K921580 for BRINK PRE-MAXILLARY IMPLANT, Substantially Equivalent on 1992-05-06. Applicant: Implantech Associates, Inc..

Clearance details

Applicant: Implantech Associates, Inc.
Product code: Code FZE
Advisory panel: General, Plastic Surgery
Date received: 1992-04-02
Decision date: 1992-05-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

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Adverse events under product code FZE

product code FZE

Injury: 138
Total: 138

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.