ADJUSTABLE THERASNORE— 510(k) K973038

Substantially Equivalent

Distar, Inc.

FDA 510(k) clearance K973038 for ADJUSTABLE THERASNORE, Substantially Equivalent on 1997-11-12. Applicant: Distar, Inc..

Clearance details

Applicant: Distar, Inc.
Product code: Code LRK
Advisory panel: Dental
Date received: 1997-08-14
Decision date: 1997-11-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Winchester, VA, 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.