# K192913: R&D Series Nova Compo-B Plus Bottle, R&D Series Nova Compo-B Plus Single Dose

- Pathway: 510(k) (Traditional)
- Applicant: Imicryl Dis Malzemeleri Sanayi VE Ticaret AS
- Decided: Jan 19, 2021 after 462 days
- Product code: KLE (Agent, Tooth Bonding, Resin)
- Device class: 2
- Regulation: 21 CFR 872.3200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K931812 (1993). 33 ancestors in all.
No later device cites it as a predicate yet.
0 of 34 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132450: Clearfil Universal Bond Value Pack, Clearfil Universaly Bond Trial, Clearfil Universal Bond, Kuraray Noritake Dental, Inc. (2013) Summary page 5.

## Indications for use
Direct restorations using light-cured composite resin Cavity sealing as a pretreatment for indirect restorations Treatment of exposed root surfaces Treatment of hypersensitive teeth Intraoral repairs of fractured restorations Post cementation and core build-ups Cementation of inlays, onlays, crowns, bridges and veneers

Source page: https://510kreport.com/device/K192913
Methodology: https://510kreport.com/methodology