# K103514: Pro-V Coat

- Pathway: 510(k) (Traditional)
- Applicant: Bisco, Inc.
- Decided: May 25, 2011 after 176 days
- Product code: EBG (Crown And Bridge, Temporary, Resin)
- Device class: 2
- Regulation: 21 CFR 872.3770
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K924132 (1993). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073263: PRO-V, Bisco, Inc. (2008) Summary page 1.

## Indications for use
Pro-V Coat is indicated for use as a separating agent when placed between any resin based material and to the substrate to which permanent bonding is not desired, such as: 1. any resin based material to the adhesive layer. 2. any resin based material to the remaining tooth structure.

Source page: https://510kreport.com/device/K103514
Methodology: https://510kreport.com/methodology