HI-WAVE; POUR-PLUS— 510(k) K011762

Substantially Equivalent

Denplus, Inc.

FDA 510(k) clearance K011762 for HI-WAVE; POUR-PLUS, Substantially Equivalent on 2001-08-23. Applicant: Denplus, Inc..

Clearance details

Applicant: Denplus, Inc.
Product code: Code EBI
Advisory panel: Dental
Date received: 2001-06-07
Decision date: 2001-08-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Longueuil, Quebec, CA

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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.