# K973919: Cavity Varnish (Intermediary Varnish and Dentinal Tubuli Seal)

- Pathway: 510(k) (Traditional)
- Applicant: Medental Intl.
- Decided: Dec 16, 1997 after 62 days
- Product code: LBH (Varnish, Cavity)
- Device class: 2
- Regulation: 21 CFR 872.3260
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Cavity varnish is used for sealing cavities before restorations. It provides a barrier against the passage of irritants from cements or other restorative materials and reduces the penetration of oral fluids at the restoration-tooth interface into the underlying dentin. It also minimizes postoperative sensitivity when applied to dentinal surfaces under newly placed restorations.

Source page: https://510kreport.com/device/K973919
Methodology: https://510kreport.com/methodology