HHC, SCORE, HENRY SCHEIN CANISTER HANDPIECE— 510(k) K080682

Substantially Equivalent

Handpiece Headquarters, Inc. - Hpr, Inc.

FDA 510(k) clearance K080682 for HHC, SCORE, HENRY SCHEIN CANISTER HANDPIECE, Substantially Equivalent on 2008-09-11. Applicant: Handpiece Headquarters, Inc. - Hpr, Inc..

Clearance details

Applicant: Handpiece Headquarters, Inc. - Hpr, Inc.
Product code: Code EFB
Advisory panel: Dental
Date received: 2008-03-10
Decision date: 2008-09-11
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Orange, CA, US

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Adverse events under product code EFB

product code EFB

Injury: 133
Malfunction: 562
Total: 695

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.