Last synced on 23 February 2024 at 11:04 pm

Profisil 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)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K230333
510(k) Type
Traditional
Applicant
Kettenbach GmbH & Co. KG
Country
Germany
FDA Decision
Substantially Equivalent
Decision Date
7/24/2023
Days to Decision
167 days
Submission Type
Summary

Profisil 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)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K230333
510(k) Type
Traditional
Applicant
Kettenbach GmbH & Co. KG
Country
Germany
FDA Decision
Substantially Equivalent
Decision Date
7/24/2023
Days to Decision
167 days
Submission Type
Summary