REMOVABLE HERBST APPLIANCE— 510(k) K955822

Substantially Equivalent

Univ. Dental Assoc. Department of Orthodontics

FDA 510(k) clearance K955822 for REMOVABLE HERBST APPLIANCE, Substantially Equivalent on 1996-03-20. Applicant: Univ. Dental Assoc. Department of Orthodontics.

Clearance details

Applicant: Univ. Dental Assoc. Department of Orthodontics
Product code: Code LRK
Advisory panel: Dental
Date received: 1995-12-26
Decision date: 1996-03-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Buffalo, NY, US

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Adverse events under product code LRK

product code LRK

Injury: 246
Malfunction: 1,044
Total: 1,290

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.