CRANE ACRYLIC HERBST APPLIANCE— 510(k) K140429

Name: FDA 510(k) clearance K140429
Creator: U.S. Food and Drug Administration
Published: 2014-09-11

Substantially Equivalent

Crane Dental Laboratory, Inc.

FDA 510(k) clearance K140429 for CRANE ACRYLIC HERBST APPLIANCE, Substantially Equivalent on 2014-09-11. Applicant: Crane Dental Laboratory, Inc.. Device class: 2.

Clearance details

Applicant: Crane Dental Laboratory, Inc.
Product code: Code LRK
Device class: Class 2
Regulation: 21 CFR 872.5570
Advisory panel: Dental
Date received: 2014-02-19
Decision date: 2014-09-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rochester, NY, 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.