PROSTHOFLEX— 510(k) K942562

Substantially Equivalent

Knopf Assoc, Inc.

FDA 510(k) clearance K942562 for PROSTHOFLEX, Substantially Equivalent on 1994-12-20. Applicant: Knopf Assoc, Inc..

Clearance details

Applicant: Knopf Assoc, Inc.
Product code: Code EBI
Advisory panel: Dental
Date received: 1994-05-31
Decision date: 1994-12-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Livingston, NJ, US

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Adverse events under product code EBI

product code EBI

Other: 1
Total: 1

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.