FDA · official record K230333Substantially EquivalentProfisil Fluoride Varnish Combi pack (14801), Profisil Fluoride Varnish Normal pack mint (14802), Profisil Fluoride Varnish Normal pack berry (14804), Profisil Fluoride Varnish Normal pack unflavored (14806), Profisil Fluoride Varnish Sample pack (14800)
United StatesLBHKettenbach GmbH & Co. KG
Official record identity
- FDA application number
- K230333
- Decision date
- July 24, 2023
- Published decision
- Substantially Equivalent
Classification
Published parties
- Applicant
- Kettenbach GmbH & Co. KG
Additional source fields
- Decision code
- SESE
- Published decision
- Substantially Equivalent
- Submission type
- Traditional
- Received date
- 2023-02-07
- Review panel
- Dental
- Current product-code class (harmonized)
- 2
- Current product-code regulation (harmonized)
- 872.3260
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.