DINABASE (TM)— 510(k) K971138

Substantially Equivalent

Sultan Chemists, Inc.

FDA 510(k) clearance K971138 for DINABASE (TM), Substantially Equivalent on 1997-07-21. Applicant: Sultan Chemists, Inc..

Clearance details

Applicant: Sultan Chemists, Inc.
Product code: Code EBI
Advisory panel: Dental
Date received: 1997-03-28
Decision date: 1997-07-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Englewood, NJ, US

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Adverse events under product code EBI

product code EBI

Other: 1
Total: 1

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.