NITE-GUIDE— 510(k) K931615

Substantially Equivalent

ORTHO-TAIN, Inc.

FDA 510(k) clearance K931615 for NITE-GUIDE, Substantially Equivalent on 1995-04-14. Applicant: ORTHO-TAIN, Inc..

Clearance details

Applicant: ORTHO-TAIN, Inc.
Product code: Code KMY
Advisory panel: Dental
Date received: 1993-04-01
Decision date: 1995-04-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chicago, IL, US

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Adverse events under product code KMY

product code KMY

Injury: 1,457
Total: 1,457

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.