DENTAL ANTI-SNORING DEVICE— 510(k) K874416

Substantially Equivalent

Ortho Publications, Inc.

FDA 510(k) clearance K874416 for DENTAL ANTI-SNORING DEVICE, Substantially Equivalent on 1988-10-18. Applicant: Ortho Publications, Inc..

Clearance details

Applicant: Ortho Publications, Inc.
Product code: Code LRK
Advisory panel: Dental
Date received: 1987-10-28
Decision date: 1988-10-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Westfield, NJ, 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.