ORTHODONTIC BITE— 510(k) K922984

Substantially Equivalent

American Orthodontics

FDA 510(k) clearance K922984 for ORTHODONTIC BITE, Substantially Equivalent on 1993-03-31. Applicant: American Orthodontics.

Clearance details

Applicant: American Orthodontics
Product code: Code LRK
Advisory panel: Dental
Date received: 1992-06-22
Decision date: 1993-03-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sheboygan, WI, 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.