PREFORMED TOOTH POSITIONER— 510(k) K780619

Substantially Equivalent

Tp Laboratories, Inc.

FDA 510(k) clearance K780619 for PREFORMED TOOTH POSITIONER, Substantially Equivalent on 1978-06-28. Applicant: Tp Laboratories, Inc..

Clearance details

Applicant: Tp Laboratories, Inc.
Product code: Code KMY
Advisory panel: Dental
Date received: 1978-04-13
Decision date: 1978-06-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, 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.