Silent Nite Sleep Appliance with the Glidewell Hinge— 510(k) K210694

Name: FDA 510(k) clearance K210694
Creator: U.S. Food and Drug Administration
Published: 2021-06-16

Substantially Equivalent

Prismatik Dentalcraft, Inc.

FDA 510(k) clearance K210694 for Silent Nite Sleep Appliance with the Glidewell Hinge, Substantially Equivalent on 2021-06-16. Applicant: Prismatik Dentalcraft, Inc.. Device class: 2.

Clearance details

Applicant: Prismatik Dentalcraft, Inc.
Product code: Code LRK
Device class: Class 2
Regulation: 21 CFR 872.5570
Advisory panel: Dental
Date received: 2021-03-08
Decision date: 2021-06-16
Decision: Substantially Equivalent
Clearance type: Special
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

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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.