PASR/QUIETNITE— 510(k) K093340

Substantially Equivalent

Exact Supplies , Ltd.

FDA 510(k) clearance K093340 for PASR/QUIETNITE, Substantially Equivalent on 2010-06-11. Applicant: Exact Supplies , Ltd..

Clearance details

Applicant: Exact Supplies , Ltd.
Product code: Code LRK
Advisory panel: Dental
Date received: 2009-10-26
Decision date: 2010-06-11
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Watlington, Oxfordshire, GB

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.