TEEN CLEAN, RETAINER CLEANER— 510(k) K860737

Substantially Equivalent

Teen Care, Inc.

FDA 510(k) clearance K860737 for TEEN CLEAN, RETAINER CLEANER, Substantially Equivalent on 1986-03-26. Applicant: Teen Care, Inc..

Clearance details

Applicant: Teen Care, Inc.
Product code: Code EFT
Advisory panel: Dental
Date received: 1986-02-27
Decision date: 1986-03-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New York, NY, US

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Adverse events under product code EFT

product code EFT

Death: 8
Injury: 267
Total: 275

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.