SNORE-CURE ANTI-SNORING APPLIANCE— 510(k) K980952

Substantially Equivalent

ORTHO-TAIN, Inc.

FDA 510(k) clearance K980952 for SNORE-CURE ANTI-SNORING APPLIANCE, Substantially Equivalent on 1998-06-01. Applicant: ORTHO-TAIN, Inc..

Clearance details

Applicant: ORTHO-TAIN, Inc.
Product code: Code LRK
Advisory panel: Dental
Date received: 1998-03-13
Decision date: 1998-06-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, 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.