TOOTHBRUSH, ORTHODONTIC, #0126-0189-00— 510(k) K771184

Substantially Equivalent

Hoyt Laboratories

FDA 510(k) clearance K771184 for TOOTHBRUSH, ORTHODONTIC, #0126-0189-00, Substantially Equivalent on 1977-07-15. Applicant: Hoyt Laboratories.

Clearance details

Applicant: Hoyt Laboratories
Product code: Code EFW
Advisory panel: Dental
Date received: 1977-06-29
Decision date: 1977-07-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code EFW

product code EFW

Injury: 143
Malfunction: 698
Total: 841

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.