SNOREMASTER— 510(k) K954128

Substantially Equivalent

D.D.S., Inc.

FDA 510(k) clearance K954128 for SNOREMASTER, Substantially Equivalent on 1995-10-02. Applicant: D.D.S., Inc..

Clearance details

Applicant: D.D.S., Inc.
Product code: Code LRK
Advisory panel: Dental
Date received: 1995-09-01
Decision date: 1995-10-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Half Moon Bay, CA, 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.