THE QUIET SLEEPER— 510(k) K012142

Substantially Equivalent

Precision Dental Laboratories, Inc.

FDA 510(k) clearance K012142 for THE QUIET SLEEPER, Substantially Equivalent on 2001-10-04. Applicant: Precision Dental Laboratories, Inc..

Clearance details

Applicant: Precision Dental Laboratories, Inc.
Product code: Code LRK
Advisory panel: Dental
Date received: 2001-07-10
Decision date: 2001-10-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fargo, ND, US

Download summary PDF View on FDA.gov ↗

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.