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FDA · official record DEN230035Unknown

DentalMonitoring

United StatesSBCDental Monitoring Sas
Official record identity
FDA application number
DEN230035
Decision date
May 17, 2024
Published decision
Unknown
Classification
Published parties
Additional source fields
Decision code
DENG
Published decision
Unknown
Submission type
Direct
Received date
2023-05-04
Review panel
Dental
Current product-code class (harmonized)
2
Current product-code regulation (harmonized)
872.1770
About this record

This record preserves an application published in the FDA 510(k) bulk export, including the DEN entries FDA includes in that export. Historical decisions do not establish current marketing status. Product-code harmonization is separate from the original application; joined establishment identifiers are not assigned to the applicant. The complete official export is checked daily and raw evidence is retained.