Cavity Varnish (Intermediary Varnish and Dentinal Tubuli Seal)
FDA 510(k) K973919 · Medental Intl.
510(k) numberK973919
Submission
- Device name
- Cavity Varnish (Intermediary Varnish and Dentinal Tubuli Seal)
- Applicant
- Medental Intl.
Evergreen, CO, US - Received
- October 15, 1997
- Decision date
- December 16, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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Questions and answers
When was Cavity Varnish (Intermediary Varnish and Dentinal Tubuli Seal) cleared by the FDA?
Cavity Varnish (Intermediary Varnish and Dentinal Tubuli Seal) (K973919) received a 510(k) decision of Substantially Equivalent on December 16, 1997, 62 days after the submission was received.
What is the product code of K973919?
The FDA product code is LBH – Varnish, Cavity, a Class II (moderate risk) device regulated under 21 CFR 872.3260.