DENTAL STAIN REMOVER— 510(k) K761352

Substantially Equivalent

Concept, Inc.

FDA 510(k) clearance K761352 for DENTAL STAIN REMOVER, Substantially Equivalent on 1977-01-03. Applicant: Concept, Inc..

Clearance details

Applicant: Concept, Inc.
Product code: Code EFW
Advisory panel: Dental
Date received: 1976-12-28
Decision date: 1977-01-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code EFW

product code EFW

Injury: 143
Malfunction: 698
Total: 841

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.